MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-05-22 for GUIDEWIRE, 1.1MM (.042') X 15' (NITINOL) 254514 manufactured by Depuy Mitek.
[615094]
The facility is reporting that during the knee procedure, the tip of the guidewire broke off in the left knee of the pt. The broken piece was retained in the knee. The procedure was completed with no harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[7956401]
Depuy mitek to date has not yet received the complaint device for eval. A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint. Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution. Therefore, we cannot determined what caused the user to experience the reported event at this time. However, the ifu states that if the nitinol guidewire becomes entrapped during screw insertion, "rotate the driver counterclockwise to back out the screw until the guidewire straightens. Pull back on the guidewire, and readvance the screw. " one hypothesis is that the guidewire may have become entrapped during the procedure, and instead of rotating the driver to remove the screw, the surgeon may have used excessive tensional force to remove the wire, causing it to weaken and break off into the pt. Based on complaint rate and customer impact, we believe this to be an anomaly. The facility is reporting that there was no pt harm; however, the broken fragment was left in the body, it is possible that pt injury could potentially occur. Because of this potentiality an mdr is being filed to document this event. When and if the complaint device is rec'd here at depuy mitek, it will be subjected to a failure root cause analysis. If the analysis identifies any definitive root cause, outside of our initial hypothesis, a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221934-2007-00113 |
| MDR Report Key | 853910 |
| Report Source | 05,06 |
| Date Received | 2007-05-22 |
| Date of Report | 2007-05-21 |
| Report Date | 2007-05-21 |
| Date Mfgr Received | 2007-05-11 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2007-12-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | DANIELLE DUFOUR |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283674 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUIDEWIRE, 1.1MM (.042') X 15' (NITINOL) |
| Generic Name | ARTHROSCOPIC INSTRUMENT |
| Product Code | LXI |
| Date Received | 2007-05-22 |
| Model Number | 254514 |
| Catalog Number | 254514 |
| Lot Number | 0611093 |
| ID Number | NA |
| Device Expiration Date | 2011-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 934607 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | RAYNHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-22 |