FDA Adverse Event
Other
Summary report: N
BIO-SUTURE TAK WITH NEEDLE, 3.0MM
MDR report key: 538421
·
Received July 21, 2004
Report
- Report Number
- 1220246-2004-00033
- Event Type
- Other
- Date Received
- July 21, 2004
- Date of Event
- December 20, 2003
- Report Date
- July 20, 2004
- Manufacturer
- ARTHREX, INC.
- Product Code
- MAI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SURGEON PLACED ANCHOR AFTER DRILLING, REMOVED SPEAR AND SPEAR GUIDE. THEN TESTED ANCHOR PLACEMENT BY PULLING BACK ON ANCHOR. ANCHOR STAYED IN PLACE BUT SUTURES (NOT EYELET) BROKE. THIS HAPPENED ON 3 ANCHORS, THE FOURTH ONE BROKE WHEN TIED KNOTS (2 FOR EACH CASE). ALL FROM THE SAME LOT. NO PT INJURY REPORTED, SURGEON RETHREADED ANCHORS WITH FIBERWIRE, HOWEVER, DELAY TIME WAS APPROX 1 HR. THIS DEVICE IS USED FOR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO-SUTURE TAK WITH NEEDLE, 3.0MM | SUTURE ANCHOR DEVICE | MAI | ARTHREX, INC. | AR-1934BN | 35747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |