MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2007-06-18 for NITINOL GUIDEWIRE 254417 manufactured by Depuy Mitek.
[651470]
Our affiliate is reporting that during an acl repair, using 2x linvatec titanium screws, the nitinol guide wire snapped off at screw insertion. The broken fragment remains within the device within the patient. The procedure was concluded successfully without further incident or harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[7976051]
At this point in time, we are awaiting receipt of the complaint device, and we are gathering whatever further pertinent data that would be germane towards discerning a root cause of the reported failure mode. When all of this is completed, the results will be reflected in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221934-2007-00144 |
| MDR Report Key | 866482 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2007-06-18 |
| Date of Report | 2007-05-24 |
| Date of Event | 2007-05-24 |
| Date Facility Aware | 2004-05-24 |
| Report Date | 2004-05-24 |
| Date Mfgr Received | 2007-05-24 |
| Date Added to Maude | 2007-06-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR ARTHUR FRIGAULT |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089773856 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NITINOL GUIDEWIRE |
| Generic Name | ARTHROSCOPIC INSTRUMENT |
| Product Code | LXI |
| Date Received | 2007-06-18 |
| Model Number | 254417 |
| Catalog Number | 254417 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 849847 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DR. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-18 |