MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-24 for ACL DISPOSABLE KIT manufactured by Depuy Mitek, Inc..
[131765602]
During surgery, while putting in a screw implant, a nitinol wire tip broke off inside the patient's knee. The wire was in the middle core of the screw and upon removal, a portion broke off, was able to be removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082562 |
| MDR Report Key | 8196262 |
| Date Received | 2018-12-24 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-12-10 |
| Date Added to Maude | 2018-12-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | ACL DISPOSABLE KIT |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2018-12-24 |
| Lot Number | L973653 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-24 |