MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-04-16 for DRILL GUIDE, 7MM TRANSTIBIAL FEMORAL ACL AR-1801 manufactured by Arthrex, Inc..
[834887]
It was reported that the tip of the guide broke off in the joint during an anterior cruciate ligament repair. The surgeon had placed the 7mm guide over the top guide through the transtibial tunnel. The tip of the guide broke as the surgeon straightened the patient's leg to get the guide to the back. The broken piece was located aided with x-rays but could not be retrieved and the surgery was delayed over 30 minutes. The customer reported a good outcome and no additional adverse consequences have been reported from this event. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[8002202]
The device evaluation confirmed the broken guide tip. Material analysis of the guide was found within specifications. Based on previous investigations, the complainant's event is typically caused when the patient's knee is flexed while the device remains inside the joint space. Product dfu cautions: "flexion of the joint with the instrument in position in the joint may result in bending or breakage of the instrument" and "after insertion of the instrument into the joint, do not apply additional flexion to the joint. A piece of a broken instrument can become lodged in soft tissue and/or disappear from the arthroscope view of the surgical field and can be left in the patient. " the initial information provided confirms the user error. The cause of this event was attributed to misuse.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2008-00063 |
| MDR Report Key | 1035378 |
| Report Source | 05,06,07 |
| Date Received | 2008-04-16 |
| Date of Report | 2008-03-18 |
| Date of Event | 2008-03-12 |
| Date Mfgr Received | 2008-03-18 |
| Device Manufacturer Date | 1994-01-01 |
| Date Added to Maude | 2009-05-05 |
| 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 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, 7MM TRANSTIBIAL FEMORAL ACL |
| Generic Name | GUIDE |
| Product Code | LXI |
| Date Received | 2008-04-16 |
| Returned To Mfg | 2008-03-21 |
| Model Number | NA |
| Catalog Number | AR-1801 |
| Lot Number | 17940129 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | NAPLES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-04-16 |