MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-01-04 for 5.5MM TITANIUM INTRALINE 2 FORCE FIBER 3910-400-050 manufactured by Stryker Endoscopy Puerto Rico.
[1419357]
It was reported that the patient was undergoing arthroscopic rotator cuff repair. A stryker titanium anchor was being screwed into place in the greater tuberosity. In doing so, the head allegedly snapped off prior to it being seated all the way. The broken piece was then removed using a synthes broken screw removal set.
Patient Sequence No: 1, Text Type: D, B5
[8507020]
Additional information will be provided once investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648666-2010-00002 |
| MDR Report Key | 1579078 |
| Report Source | 04 |
| Date Received | 2010-01-04 |
| Date of Report | 2009-12-07 |
| Date of Event | 2009-11-09 |
| Date Mfgr Received | 2009-12-07 |
| Date Added to Maude | 2010-08-04 |
| 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 | NILA PATEL |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY PUERTO RICO |
| Manufacturer Street | HWY. #3, KM. 130.2 LAS PALMAS INDUSTRIAL PARK |
| Manufacturer City | ARROYO PR 00615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5.5MM TITANIUM INTRALINE 2 FORCE FIBER |
| Generic Name | ANCHOR |
| Product Code | NOV |
| Date Received | 2010-01-04 |
| Catalog Number | 3910-400-050 |
| Lot Number | 09233AE2 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY PUERTO RICO |
| Manufacturer Address | ARROYO PR 00615 US 00615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-04 |