MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-10-23 for NITINOL GUIDEWIRE 254514 manufactured by Depuy Mitek.
[538390]
Received a 3500 from a facility stating that a patient had knee surgery. Two days later, a follow up examine, x-ray, revealed some foreign material in the bone tunnel, which turned out to be a portion, approximately 7. 2cm, of the distal tip of a nitinol guidewire used in the knee repair. Re-surgery was had on this date and the guidewire fragment removed. Again, the acl was re-fixated to remedy the patient's issue. The case was concluded successfully without further incident or harm to the patient. The device was discarded by the facility. No lot number was supplied. Mitek notified on october 18, 2006.
Patient Sequence No: 1, Text Type: D, B5
[7919771]
The facility has discarded the complaint device, and no lot number has been supplied both of which preclude conducting a physical analysis and conducting a batch record review to determine if there were any internal processing issues which would have contributed to the nature of the product complaint. A review into the mitek complaints system revealed 2 other similar incidents over the life of the device. We cannot discern a root cause for the reported failure mode. We consider this event to be an anomaly, and at this point in time, barring any further pertinent and germane information being received, no further action is warranted. However, mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221934-2006-00224 |
| MDR Report Key | 772931 |
| Report Source | 05,06 |
| Date Received | 2006-10-23 |
| Date of Report | 2006-10-18 |
| Date of Event | 2006-09-05 |
| Date Facility Aware | 2006-09-07 |
| Report Date | 2006-10-18 |
| Date Mfgr Received | 2006-10-18 |
| Date Added to Maude | 2006-10-26 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ARTHUR FRIGAULT |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | 5089773856 |
| Manufacturer G1 | DEPUY MITEK |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| 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 | 2006-10-23 |
| Model Number | 254514 |
| Catalog Number | 254514 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 760716 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DRIVE * US |
| Baseline Brand Name | INTRAFIX 1.1MM X 15" NITENOL GUIDE WIRE |
| Baseline Generic Name | ARTHOROSCOPIC INSTRUMENT |
| Baseline Model No | 254514 |
| Baseline Catalog No | 254514 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-10-23 |