MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-12-28 for 5.5MM TITANIUM INTRALINE W NEEDLES 2 FORCE FIBER 3910400055 manufactured by Stryker Endoscopy Puerto Rico.
[1442401]
It was reported that, during a rotator cuff repair - open approach, the doctor implanted anchor and it broke in the bone. The broken part of the anchor was retrieved from the bone and a different anchor was used to complete the surgery.
Patient Sequence No: 1, Text Type: D, B5
[8511990]
Additional information will be provided once investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648666-2009-00382 |
| MDR Report Key | 1577075 |
| Report Source | 07 |
| Date Received | 2009-12-28 |
| Date of Report | 2009-11-30 |
| Date of Event | 2009-11-30 |
| Date Mfgr Received | 2009-11-30 |
| Device Manufacturer Date | 2008-05-28 |
| 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 COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY PUERTO RICO |
| Manufacturer Street | LAS PALMAS INDUSTRIAL PARK HIGHWAY #3 KM 130.2 |
| 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 W NEEDLES 2 FORCE FIBER |
| Generic Name | ANCHOR |
| Product Code | NOV |
| Date Received | 2009-12-28 |
| Catalog Number | 3910400055 |
| Lot Number | 09148AE2 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2009-12-28 |