MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2009-05-11 for BIO-TRANSFIX, 5MM X 40MM AR-1351B manufactured by Arthrex, Inc..
[21781983]
It was reported that the head of the implant broke off during an acl repair, but the shaft remained in the pt. As the implant was being seated into the bone, the threaded end began to crack and break off. All loose pieces that broke off were retrieved, but the body of the implant remained un-retrieved from the bone due to good fixation of the graft. The surgery was reported as completed successfully with the implant as is; no add'l implants were used. No further pt info was provided at the time of this report or made available in response to f/u communication. No add'l adverse consequences have been reported from this event. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[21865049]
The device was requested for eval, but was not returned because it had been discarded by the facility; therefore, the complainant's event could not be verified. The cause of the event could not be determined from the info available and without device eval. Device history record review revealed nothing relevant to this event. Based on the info provided, the most likely cause of this type of event is improper bone preparation, inserting the implant at an angle that is not perpendicular to the pilot hole, prying/leveraging the driver while the implant is still loaded, or applying excessive force to the screw during implantation. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2009-00074 |
| MDR Report Key | 1380608 |
| Report Source | 06,07 |
| Date Received | 2009-05-11 |
| Date of Report | 2009-04-17 |
| Date of Event | 2009-04-15 |
| Date Mfgr Received | 2009-04-17 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2010-02-01 |
| 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, 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 | BIO-TRANSFIX, 5MM X 40MM |
| Product Code | MNU |
| Date Received | 2009-05-11 |
| Model Number | NA |
| Catalog Number | AR-1351B |
| Lot Number | 176158 |
| ID Number | NA |
| Device Expiration Date | 2010-07-01 |
| 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. Other | 2009-05-11 |