MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-12-22 for BIO-TRANSFIX, 5MM X 40MM, LONG AR-1351B manufactured by Arthrex, Inc..
[999696]
It was reported that at 6 months post-op, an x-ray revealed the implant had broken. The patient had already healed from the acl procedure so the implant was subsequently removed. No further patient information was provided at the time of this report or in follow-up communication. No additional adverse consequences have been reported from this event. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[8166844]
The device was requested for evaluation but was not released by the facility risk management, therefore the complainant's event could not be verified. The cause of the event could not be determined from the information available and without device evaluation. Device history record review revealed nothing relevant to this event. Based on the information provided, the most likely cause of this type of event is graft wire that is not inserted straight. If, during insertion, the graft wire is passed through the graft and it is not straight, the implant will tend to conform to the same path as the graft passing wire. Constant and/or dynamic load placed on the implant after time in vivo can lead to plastic deformation and breakage. This is the first complaint of this type for this part/lot combination. The potential causes of this event are being communicated to the event reporter. If the device is returned and additional relevant information is obtained, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2008-00252 |
| MDR Report Key | 1272868 |
| Report Source | 05,06 |
| Date Received | 2008-12-22 |
| Date of Report | 2008-11-24 |
| Date of Event | 2008-11-24 |
| Date Mfgr Received | 2008-11-24 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2009-01-14 |
| 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 | PATRICIA HILBRANDS, SENIOR 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 | BIO-TRANSFIX, 5MM X 40MM, LONG |
| Product Code | MNU |
| Date Received | 2008-12-22 |
| Model Number | NA |
| Catalog Number | AR-1351B |
| Lot Number | 141541 |
| ID Number | NA |
| Device Expiration Date | 2010-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | NAPLES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-12-22 |