MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2013-03-21 for UNKNOWN ZIMMER DRILL BIT manufactured by Zimmer, Inc..
[3201421]
It was reported that the tip of the drill bit broke off in the patient's patella.
Patient Sequence No: 1, Text Type: D, B5
[10596181]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2013-00511 |
| MDR Report Key | 3034761 |
| Report Source | 05,06,08 |
| Date Received | 2013-03-21 |
| Date of Report | 2013-02-22 |
| Date of Event | 2013-02-12 |
| Date Mfgr Received | 2013-02-22 |
| Date Added to Maude | 2013-05-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ZIMMER DRILL BIT |
| Generic Name | KNEE INSTRUMENT |
| Product Code | HTT |
| Date Received | 2013-03-21 |
| Returned To Mfg | 2013-02-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-21 |