MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2007-09-14 for DRILL GUIDE, 7MM TRANSTIBIAL FEMORAL ACL AR-1801 manufactured by Arthrex, Inc..
[692085]
It was reported that the tip broke off in the patient's knee. The surgery was delayed approximately 1 hour due to x-rays performed. The tip could not be retrieved but no adverse consequences have been reported as a result of this event. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[7853628]
Evaluation confirmed the customer's complaint. The tip of the device has broken off and was not returned. Material verification met specifications and nothing relevant to the event was found during the device history review. It appears that the tip broke off due to prying. This event was attributed to misuse.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2007-00193 |
| MDR Report Key | 914503 |
| Report Source | 01,05,08 |
| Date Received | 2007-09-14 |
| Date of Report | 2007-08-23 |
| Date of Event | 2007-08-01 |
| Date Mfgr Received | 2007-08-23 |
| Device Manufacturer Date | 1994-07-01 |
| Date Added to Maude | 2007-11-08 |
| 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, SR. ANALYST |
| Manufacturer Street | 1370 CREEKSIDE BLVD. |
| 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, 7MM TRANSTIBIAL FEMORAL ACL |
| Generic Name | GUIDE |
| Product Code | LXI |
| Date Received | 2007-09-14 |
| Returned To Mfg | 2007-09-04 |
| Model Number | NA |
| Catalog Number | AR-1801 |
| Lot Number | 17942829 |
| ID Number | NA |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 899185 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | NAPLES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-14 |