MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 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.
[18582170]
It was reported that, while using a posterior approach, the doctor inserted the 1st anchor with 12 degree guide to repair posterior labral tear at the 7 o'clock position. After initial insertion into pilot hole by hand he began malleting. Anchor would not advanced past approx 70% insertion. He began to aggressively mallet the anchor and believes that he blew it out through the glenoid. It was further reported that the second anchor was inserted through a 0 degree guide at the 8 o'clock position. After insertion by hand he began malleting but the anchor would not advance. At this point, he did not feel comfortable continuing with this process so he attempted to remove the anchor. Anchor would not detach, so using...
Patient Sequence No: 1, Text Type: D, B5
[18687598]
Additional info will be provided once investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648666-2010-00004 |
| MDR Report Key | 1580640 |
| Report Source | 07 |
| Date Received | 2010-01-05 |
| Date of Report | 2009-12-08 |
| Date of Event | 2009-12-08 |
| Date Mfgr Received | 2009-12-08 |
| 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 PUERTO RICO, LTD. |
| 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 | UNK |
| 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 | 2010-01-05 |