MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-12-14 for CRILE-WOOD NEEDLE HOLDER, 18CM, TC, FINE 36-06508 manufactured by Stryker Osteosynthesis Freiburg.
[17096124]
During suture, the needle holder broke suddenly. Surgeon said, there was no physical collision.
Patient Sequence No: 1, Text Type: D, B5
[17405576]
Investigation in progress but not yet complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010177-2011-00381 |
| MDR Report Key | 2411182 |
| Report Source | 01 |
| Date Received | 2011-12-14 |
| Date of Report | 2011-11-21 |
| Date of Event | 2011-11-16 |
| Date Mfgr Received | 2011-11-21 |
| Date Added to Maude | 2012-02-10 |
| 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 | JAMSHED BADARPURA |
| Manufacturer Street | 750 TRADE CENTRE WAY SUITE 200 |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693894260 |
| Manufacturer G1 | STRYKER OSTEOSYNTHESIS FREIBURG |
| Manufacturer Street | BOTZINGER STRASSE 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRILE-WOOD NEEDLE HOLDER, 18CM, TC, FINE |
| Generic Name | INSTRUMENT |
| Product Code | HXK |
| Date Received | 2011-12-14 |
| Returned To Mfg | 2011-12-05 |
| Model Number | NA |
| Catalog Number | 36-06508 |
| Lot Number | Z4 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER OSTEOSYNTHESIS FREIBURG |
| Manufacturer Address | FREIBURG D-79111 GM D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-14 |