MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-05 for 3.5 MM PEEK TWINLOOP FLEX ONE STRAND 2 FORCE FIBER 3910-405-638 manufactured by Stryker Endoscopy Puerto Rico.
[2657669]
It was reported that during a shoulder arthroscopy procedure, after the surgeon implanted the anchor, the thread broke and separated from the anchor unit. The account reports that this has occurred before. The procedure was completed successfully with another item.
Patient Sequence No: 1, Text Type: D, B5
[9883850]
A quantity of three units, from the same lot number, were implicated in this event. Please refer to medwatch report numbers: 2648666-2012-00191, 00192. Add'l info will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648666-2012-00193 |
| MDR Report Key | 2607955 |
| Report Source | 07 |
| Date Received | 2012-06-05 |
| Date of Report | 2012-05-11 |
| Date of Event | 2012-05-07 |
| Date Mfgr Received | 2012-05-11 |
| Date Added to Maude | 2012-10-02 |
| 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 | TOM SHAFER |
| 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 | HWY. 3, KM. 130.2 LAS PALMAS IND. 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 | 3.5 MM PEEK TWINLOOP FLEX ONE STRAND 2 FORCE FIBER |
| Generic Name | SHOULDER FIXATION ANCHOR |
| Product Code | NOV |
| Date Received | 2012-06-05 |
| Catalog Number | 3910-405-638 |
| Lot Number | 11276AE2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-06-05 |