MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2005-06-29 for 3/8" STARTER DRILL 7650-1033 manufactured by Stryker Orthopaedics Mahwah.
[465960]
During surgery, when the drill was withdrawn from the femur, a part of the drill tip was missing. This part had allegedly stayed behind in the pt. Retrieval of the fragment was attempted during surgery, but it could not be located.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249697-2005-00072 |
| MDR Report Key | 736327 |
| Report Source | 01,07 |
| Date Received | 2005-06-29 |
| Date of Report | 2005-06-03 |
| Date of Event | 2005-06-01 |
| Date Mfgr Received | 2005-06-03 |
| Device Manufacturer Date | 1996-05-01 |
| Date Added to Maude | 2006-07-20 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JANICE PEVIDE |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3/8" STARTER DRILL |
| Generic Name | INSTRUMENT |
| Product Code | HBG |
| Date Received | 2005-06-29 |
| Model Number | NA |
| Catalog Number | 7650-1033 |
| Lot Number | DR50567 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 724216 |
| Manufacturer | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Address | * MAHWAH NJ 07430 US |
| Baseline Brand Name | 3/8" STARTER DRILL |
| Baseline Generic Name | SURGICAL INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 7650-1033 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-06-29 |