MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2008-06-05 for NITINOL GUIDEWIRE, ACL DISPOSABLE UNK UNK INSTRUMENT manufactured by Depuy Mitek.
[19162693]
We received a 3500 via the fda that was generated by the user facility. The report states that a patient underwent a pcl (posterior crucial ligament) repair of the left knee in 2008. A post operative x ray revealed a foreign body near the fixation device. A re-surgery was had on two weeks later, to remove the foreign matter which was identified, as a portion of the distal end of a nitinol guide wire which had broken off during the original procedure. The fragment was retrieved from the body without further issue or harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[19326010]
Phone conversation with the 3500 co rep on june 4, 2008. The contact stated that; complaint device was discarded; event may have been technique driven; the staff is now on alert to insure that in the future, they will insure that instrumentation is "whole" when removed from the body; the patient is fine. This is all of the information and event status that can be made available. At this point in time, no further action is warranted. However, this file will remain receptive for any potentially pertinent forthcoming information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221934-2008-00298 |
| MDR Report Key | 1057543 |
| Report Source | 00,05,06 |
| Date Received | 2008-06-05 |
| Date of Report | 2008-05-30 |
| Date of Event | 2008-05-14 |
| Date Facility Aware | 2008-05-14 |
| Report Date | 2008-05-30 |
| Date Reported to FDA | 2008-05-20 |
| Date Mfgr Received | 2008-05-30 |
| Date Added to Maude | 2008-06-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ARTHUR FRIGAULT |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089773856 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NITINOL GUIDEWIRE, ACL DISPOSABLE |
| Generic Name | ARTHROSCOPIC INSTRUMENT |
| Product Code | LXI |
| Date Received | 2008-06-05 |
| Model Number | UNK |
| Catalog Number | UNK INSTRUMENT |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1026387 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DRIVE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-06-05 |