MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for ARTHREX? AR-1317FT manufactured by Arthrex, Inc..
[184709588]
During a right middle finger flexor tendon reconstruction with autograft, two anthrex nano suture anchors broke, while securing a tendon. Additional suture anchors were used successfully to fixate the tendon. Implant name: suture anchor, nano corkscrew ft with 3-0 fiberwire suture with two 1/2 circle taper point needles with k-wires.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9871415 |
| MDR Report Key | 9871415 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-14 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Reported to Mfgr | 2020-03-24 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHREX? |
| Generic Name | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
| Product Code | MBI |
| Date Received | 2020-03-24 |
| Model Number | AR-1317FT |
| Catalog Number | AR-1317FT |
| Lot Number | 10503127 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BLVD NAPLES FL 34108 US 34108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |