MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for DISPS KIT, TRANS-TIB ACL W/SAWBLD GUIDEWIRE AR-1897S manufactured by Arthrex, Inc..
[180042039]
Approximately 3 inches of guidewire broke and was retained in the patient after acl surgery. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092977 |
| MDR Report Key | 9706473 |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-10 |
| Date of Event | 2019-12-16 |
| Date Added to Maude | 2020-02-13 |
| 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 | 3 |
| 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 | DISPS KIT, TRANS-TIB ACL W/SAWBLD GUIDEWIRE |
| Generic Name | BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL |
| Product Code | GFA |
| Date Received | 2020-02-12 |
| Model Number | AR-1897S |
| Catalog Number | AR-1897S |
| Lot Number | 10440466 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-12 |