MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2007-04-13 for BIO-TRANSFIX, 5MM X 40MM, LONG AR-1351B manufactured by Arthrex, Inc..
[20162759]
It was reported that the implant broke in several parts during the surgery. The dr did not get all the pieces, then used a drill to make a hole facilitating the entrance of another implant. It is not clear from the info available if all the broken pieces were retrieved from the pt. Add'l info has been requested from the foreign distributor. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[20447174]
Investigation has been initiated, but has not been completed yet. A f/u report will be submitted upon completion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2007-00064 |
| MDR Report Key | 940129 |
| Report Source | 01,06,08 |
| Date Received | 2007-04-13 |
| Date of Report | 2007-04-11 |
| Date of Event | 2007-03-14 |
| Date Mfgr Received | 2007-03-22 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2007-11-13 |
| 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 MDR |
| Manufacturer Street | 1370 CREEDKSIDE BLVD. |
| 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 | 2007-04-13 |
| Returned To Mfg | 2007-04-05 |
| Model Number | NA |
| Catalog Number | AR-1351B |
| Lot Number | 64067 |
| ID Number | NA |
| Device Expiration Date | 2007-07-01 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 912391 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | * NAPLES FL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-13 |