MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-02-10 for BIGLIANI/FLATOW PEGGED GLENOID DRILL GUIDE 00430107746 manufactured by Zimmer, Inc..
[1918501]
It is reported that the drill bit bound up within the pegged drill guide causing the guide's handle to be torqued and fractured off. Everything was retrieved from the patient.
Patient Sequence No: 1, Text Type: D, B5
[8836162]
Evaluation summary: the returned device was inspected per print and all features were found conforming with the exception of the fracture. The guide holes show signs of significant wear from its potential field life of approximately 5. 5 years and has been used an unknown number of times during that timeframe. It is likely that damage to the guide was accrued during previous use and this damage caused interference between the guide and drill bit. This interference generated a burr that became trapped in the guide causing the bit to bind up and applying rotational forces on the guide, it was not designed for. These rotational forces caused the handle to fracture. This fracture can most likely be attributed to normal wear and tear. Evaluation: review of the device history records did not find any deviations or anomalies. 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 investigation, 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 | 1822565-2011-00216 |
| MDR Report Key | 2020504 |
| Report Source | 05,08 |
| Date Received | 2011-02-10 |
| Date of Report | 2011-01-14 |
| Date of Event | 2011-01-07 |
| Date Mfgr Received | 2011-01-14 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2011-03-31 |
| 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 | BIGLIANI/FLATOW PEGGED GLENOID DRILL GUIDE |
| Product Code | LXI |
| Date Received | 2011-02-10 |
| Returned To Mfg | 2011-01-14 |
| Catalog Number | 00430107746 |
| Lot Number | 60303450 |
| 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 | 2011-02-10 |