MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2010-02-08 for FEMORAL TRIAL DRILL GUIDE LM/RL 5650-1-712 manufactured by Stryker Orthopaedics Mahwah.
[1460960]
It was reported that, "while testing whether the drill would pass thru the bushing the drill bit became stuck in the guide. Another tray was available and opened that bushing was used without problem. After cleaning other attempts to pass a drill bit failed as well. "
Patient Sequence No: 1, Text Type: D, B5
[8498167]
Method: visual examination, device history review, complaint history review, functional testing. Results: visual examination confirms the reported event. Device history review shows no reported discrepancies. Complaint history review shows there has been other reported events. Functional testing confirms the reported event. Conclusion: appears to be user related.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2249697-2010-00091 |
| MDR Report Key | 1609506 |
| Report Source | 00,07 |
| Date Received | 2010-02-08 |
| Date of Report | 2008-07-15 |
| Date of Event | 2008-07-15 |
| Date Mfgr Received | 2008-07-15 |
| Device Manufacturer Date | 2007-12-30 |
| Date Added to Maude | 2010-10-18 |
| 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 | TERESA CLIFFORD |
| 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 | 2010-02-08 |
| Returned To Mfg | 2008-08-12 |
| 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 | 2010-02-08 |