MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-01-05 for 3.5MM PEEK TWINLOOP FLEX ONE STRAND 2 FORCE FIBER 3910-405-638 manufactured by Stryker Endoscopy Puerto Rico.
[1315747]
It was reported that upon insertion of the flex guide, the anchor went in about half way and then it would not proceed any further. It was further reported that they went in with an arthroscopic shaver blade and shaved off the excess anchor that was protruding out of the first one. Another anchor had to be placed next to the first one.
Patient Sequence No: 1, Text Type: D, B5
[8344095]
Additional information will be provided once investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648666-2010-00011 |
| MDR Report Key | 1581817 |
| Report Source | 04 |
| Date Received | 2010-01-05 |
| Date of Report | 2009-12-09 |
| Date of Event | 2009-11-24 |
| Date Mfgr Received | 2009-12-09 |
| 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 | HIGHWAY #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 | 3.5MM PEEK TWINLOOP FLEX ONE STRAND 2 FORCE FIBER |
| Generic Name | ANCHOR |
| Product Code | NOV |
| Date Received | 2010-01-05 |
| Catalog Number | 3910-405-638 |
| Lot Number | 09275AE2 |
| Operator | OTHER |
| 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 | 2010-01-05 |