MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,07 report with the FDA on 2006-07-14 for BIO TRANSFIX, 5MM X 40MM, LONG AR-1351B manufactured by Arthrex, Inc..
[20617110]
Bio-transfix broke as soon as the surgeon tugged down the acl repair. Implant snapped at the middle. Surgeon removed a piece of the broken implant and put a bio delta interference screw up the femoral tunnel to complete the repair. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[20822814]
Device was not returned for evaluation and the customer's complaint could not be verified. Dhr review revealed nothing relevant to this event. No similar complaints have been reported for this part number and there are no more of this lot in stock. The cause of the event could not be determined without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2006-00111 |
| MDR Report Key | 769541 |
| Report Source | 00,06,07 |
| Date Received | 2006-07-14 |
| Date of Report | 2006-07-11 |
| Date of Event | 2006-06-28 |
| Date Mfgr Received | 2006-06-28 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2006-10-17 |
| 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 | 3 |
| 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 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO TRANSFIX, 5MM X 40MM, LONG |
| Generic Name | BIO ABSORBABLE FIXATION DEVICE |
| Product Code | MNU |
| Date Received | 2006-07-14 |
| Model Number | NA |
| Catalog Number | AR-1351B |
| Lot Number | 57610 |
| ID Number | NA |
| Device Expiration Date | 2007-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 757380 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | * NAPLES FL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-14 |