MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-10-19 for ALL THREAD PEEK ANCHOR * manufactured by Biomet, Inc..
[19903486]
During the surgical procedure, open rotator cuff repair, suture anchors were inserted and when the orthopedic surgeon attempted to release the handle from the anchor to remove the inserter shaft implant would not dislodge. This failed twice. Patient's care was not compromised. Hand suturing was completed by the surgeon due to the failure. Sales representtive was notified of the product failure. Lot#306850. According to a biomet correspondence, there was a delay of 20 minutes and approximately 10mm of bone was removed when the anchors pulled out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1212470 |
| MDR Report Key | 1212470 |
| Date Received | 2008-10-19 |
| Date of Report | 2008-10-19 |
| Date of Event | 2008-10-02 |
| Report Date | 2008-10-19 |
| Date Reported to FDA | 2008-10-19 |
| Date Added to Maude | 2008-10-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL THREAD PEEK ANCHOR |
| Generic Name | SUTURE ANCHOR |
| Product Code | KGS |
| Date Received | 2008-10-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 306850 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1258928 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | 56 EAST BELL DRIVE WARSAW IN 465810587 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-19 |