MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-08-13 for FEMORAL TRIAL DRILL GUIDE LM/RL 5650-1-712 manufactured by Stryker Orthopaedics Mahwah.
[1184925]
It was reported that, the peg drills seized inside pkr drill guide during surgery.
Patient Sequence No: 1, Text Type: D, B5
[8370676]
Additional lot: p2s40. Device manufacture date for lot p2s40: 01/09/2008. Evaluation summary: this event is related to a trend of similar events where the drill "cold welds" (seizes) inside the pkr drill guide due to a slightly undersized condition. The results of the investigation performed indicated that there was potential for some slight variation in the hole diameter due to the manufacturing process. Corrective actions were implemented to prevent the likelihood of similar events. This is the same patient/event as mfr #2249697-2009-00486.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2249697-2009-00485 |
| MDR Report Key | 1489440 |
| Report Source | 07 |
| Date Received | 2009-08-13 |
| Date of Report | 2009-07-14 |
| Date of Event | 2009-07-14 |
| Date Mfgr Received | 2009-07-14 |
| Device Manufacturer Date | 2008-01-09 |
| Date Added to Maude | 2009-12-03 |
| 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 | JADWIGA DEGRADO |
| Manufacturer Street | 325 CORPORATE DR. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Street | 325 CORPORATE DR. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMORAL TRIAL DRILL GUIDE LM/RL |
| Generic Name | INSTRUMENT |
| Product Code | LXI |
| Date Received | 2009-08-13 |
| Returned To Mfg | 2009-07-20 |
| Model Number | NA |
| Catalog Number | 5650-1-712 |
| Lot Number | P2S39 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Address | MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-08-13 |