UNKNOWN ZIMMER DRILL BIT
Received Mar 21, 2013 · Event occurred Feb 12, 2013
Report 1822565-2013-00511 · MDR key 3034761
Device
Generic name
Knee Instrument
Manufacturer
Zimmer, Inc.Product problems
- Fracture
Patient
65 YR
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE TIP OF THE DRILL BIT BROKE OFF IN THE PATIENT'S PATELLA.
Additional Manufacturer Narrative
EVALUATION SUMMARY: THE POTENTIAL FIELD AGE OF THE DEVICE COULD NOT BE DETERMINED. THE MANNER OF USE OF THE DRILL BIT THAT LED TO THIS EVEN TIS UNKNOWN. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. RETURNED FOR REVIEW IS AN UNKNOWN DRILL BIT THAT HAS FRACTURED JUST BELOW THE START OF THE CUTTING FLUTES. DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED AND REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.