MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2011-10-25 for DRILL BRACE WITHOUT CHUCK ORIGINAL HOFFMANN 5054-2-002 manufactured by Stryker Osteosynthesis Selzach.
[2364527]
During external fixation surgery, the surgeon inserted apex pin in the bone of the pt by using drill brace. While the surgeon was inserting the pin, the screw (the check tightener) at the tip of drill brace broke. Therefore the surgery was completed by using another device.
Patient Sequence No: 1, Text Type: D, B5
[9464974]
A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8031020-2011-00231 |
| MDR Report Key | 2337941 |
| Report Source | 01,05,07 |
| Date Received | 2011-10-25 |
| Date of Report | 2011-10-04 |
| Date of Event | 2011-10-03 |
| Date Mfgr Received | 2011-10-04 |
| Date Added to Maude | 2012-03-28 |
| 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 | SANDRA SPOKANE |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER OSTEOSYNTHESIS SELZACH |
| Manufacturer Street | BOHNACKERWEG 1 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL BRACE WITHOUT CHUCK ORIGINAL HOFFMANN |
| Generic Name | INSTRUMENT |
| Product Code | HXY |
| Date Received | 2011-10-25 |
| Model Number | NA |
| Catalog Number | 5054-2-002 |
| Lot Number | J373852 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER OSTEOSYNTHESIS SELZACH |
| Manufacturer Address | SELZACH 2545 SZ 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-25 |