Device product
JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
Z-2399-2012
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 62391
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62
- Official record key
device-enforcement:Z-2399-2012
Official wording
Reason: Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.
Code information: REF. 912064 LOT 121040, 497540, 839530
Distribution pattern: Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.
Derived failure modes
-
Unknown
Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.