MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-06-01 for FEMORAL TRIAL DRILL GUIDE LM/RL 5650-1-712 manufactured by Ststryker Orthopaedics Mahwah.
[20156616]
It was reported that, "pkr 1-2 drill did not fit into drill guide. "
Patient Sequence No: 1, Text Type: D, B5
[20375826]
Evaluation summary: pkr drill guide involved in the event was not returned for evaluation. However, 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. User initializing power prior to either full engagement of the drill with the drill guide or off axis loading after full engagement of the drill through the drill guide hole could be contributing factors to binding. Complaint history review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2249697-2009-00300 |
| MDR Report Key | 1449261 |
| Report Source | 07 |
| Date Received | 2009-06-01 |
| Date of Report | 2009-05-01 |
| Date of Event | 2009-05-01 |
| Date Mfgr Received | 2009-05-01 |
| Date Added to Maude | 2009-10-06 |
| 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 | 2009-06-01 |
| Model Number | NA |
| Catalog Number | 5650-1-712 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STSTRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Address | MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-06-01 |