MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-14 for ORTHOSORB 1 PIN 50X1.3MM KIT N/A 841070 manufactured by Biomet Orthopedics.
[4035537]
It was reported that a patient underwent a bunionectomy on (b)(6) 2013. During the procedure, the orthosorb pin fractured. Another pin was utilized to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[11431452]
Manufacturing history necessary was not provided for review. Current information is insufficient to permit a conclusion as to the cause of the event. The following sections could not be completed with the limited information provided. Date of event - unknown. Expiration date - unknown. Manufacture date? Unknown. Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11550994]
Examination of returned device found no evidence of product non-conformance. During the evaluation, it was noted there were spiral abrasions, scratches & gouges leading up to the fracture. The spiral pattern suggests the shaft contacted a hard metal object during rotation.
Patient Sequence No: 1, Text Type: N, H10
[21663589]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2014-00433 |
| MDR Report Key | 3573284 |
| Report Source | 07 |
| Date Received | 2014-01-14 |
| Date of Report | 2014-03-19 |
| Date of Event | 2013-12-13 |
| Date Mfgr Received | 2014-03-19 |
| Device Manufacturer Date | 2013-06-26 |
| Date Added to Maude | 2014-01-14 |
| 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 | MS. AMANDA ZAJICEK |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726782 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOSORB 1 PIN 50X1.3MM KIT |
| Generic Name | PIN, FIXATION |
| Product Code | OVZ |
| Date Received | 2014-01-14 |
| Returned To Mfg | 2013-12-27 |
| Model Number | N/A |
| Catalog Number | 841070 |
| Lot Number | 389436 |
| ID Number | N/A |
| Device Expiration Date | 2018-06-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-14 |