MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2008-10-06 for BIO-TRANSFIX, 5MM X 40MM, LONG AR-1351B manufactured by Arthrex, Inc..
[927330]
It was reported that an acl revision surgery was performed due to the patient complaining of pain where a transfix pin was implanted. From the revision, the surgeon found the implant was cracked down the middle. He removed the piece that was not engaged, left the remaining piece as it was, and completed the revision case. Follow-up with the reporter provided information that the revision occurred 4 months post-op; the initial implant was on (b) (6) 2008 and the revision was on (b) (6) 2008. The broken piece of the screw was removed in the revision case. The implant was reported to have been 3/4 seated. The patient bone quality was reported as average. No further information was provided at the time of this report or made available in response to 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
[8211466]
The device was received for evaluation. Visual inspection revealed a bow/bend at the mid-point of the device. Stress/scuff marks were on the implant directly where the bow/bend was present; there was no actual crack confirmed in the device. In addition, the distal tip of the implant was deformed to an oval shape. The lot number was requested but not provided from the report of the initial surgery and could not be determined from device evaluation. Dhr could not be reviewed and manufacturing date could not be determined since the lot number was not 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 four months in vivo could have caused the plastic deformation (bow/bend) in this case. In addition, when the implant was seated, the wire most likely caused the id (inner diameter) at the tip to deform as well. This condition was not detrimental to the performance of the device, but helped to confirm the evaluation conclusion that the graft wire was most likely not inserted straight. The possible root cause of this event was determined as misuse by user. This is the first complaint of this part number. The potential causes of this event are being communicated to the event reporter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2008-00197 |
| MDR Report Key | 1200203 |
| Report Source | 06,07 |
| Date Received | 2008-10-06 |
| Date of Report | 2008-09-08 |
| Date of Event | 2008-09-04 |
| Date Mfgr Received | 2008-09-08 |
| 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, COMPLAINT ANAL |
| 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 | 2008-10-06 |
| Returned To Mfg | 2008-09-18 |
| Model Number | NA |
| Catalog Number | AR-1351B |
| Lot Number | UNK |
| 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 | 2008-10-06 |