MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-24 for SEMI-FIX MARKING HOOK AR-1887 manufactured by Arthrex, Inc..
[21623356]
Instrument used to place ligament graft in fossa in acl repair. Found one tine missing after case finished. X-ray showed metal tine in joint but not free floating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008940 |
| MDR Report Key | 32234 |
| Date Received | 1996-04-24 |
| Date of Report | 1996-04-19 |
| Date of Event | 1996-04-15 |
| Date Added to Maude | 1996-04-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEMI-FIX MARKING HOOK |
| Generic Name | MARKING HOOK |
| Product Code | KIK |
| Date Received | 1996-04-24 |
| Model Number | AR-1887 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33505 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 3050 N HORSESHOE DR NAPLES FL 33941 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-04-24 |