MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-07-17 for DRILL GUIDE, 6MM TRANSTIBIAL FEMORAL AR-1804 manufactured by Arthrex, Inc..
[15165310]
It was reported that the patient was undergoing an outpatient operation when an unidentified 6 mm guidewire was noticed inside the patient. The guidewire was removed during the procedure. The patient had undergone an anterior cruciate ligament reconstruction in 2007 (approximately 1 year before) at a different facility. Arthrex inc. Had not been notified of any events during this period involving any guidewires breaking and being left in the patient. The reporter could not provide the actual part number of the guidewire recovered from the patient, and it cannot be verified that this device was in fact an arthrex device from the information provided. The part number referenced in this report was used for reporting purposes only. No further patient information is available and no additional adverse consequences were reported from this event. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[15173212]
The device was not returned and the complainant's event could not be verified. The lot number was not provided, therefore, the device history record could not be reviewed and the manufacturing date was not determined. The cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2008-00142 |
| MDR Report Key | 1078383 |
| Report Source | 05,06 |
| Date Received | 2008-07-17 |
| Date of Report | 2008-06-23 |
| Date of Event | 2008-02-01 |
| Date Mfgr Received | 2008-06-23 |
| Date Added to Maude | 2008-07-29 |
| 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 | 0 |
| Manufacturer Contact | IVETTE GALMEZ, GARY DORROUGH |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| Manufacturer Phone | 8009337001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL GUIDE, 6MM TRANSTIBIAL FEMORAL |
| Generic Name | GUIDE |
| Product Code | LXI |
| Date Received | 2008-07-17 |
| Model Number | NA |
| Catalog Number | AR-1804 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1048163 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | NAPLES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-07-17 |