MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-16 for ORTHOSORB 1 PIN 50X1.3MM KIT N/A 841070 manufactured by Biomet Orthopedics.
[18806913]
It was reported that patient underwent a bunnionectomy utilizing a pin on (b)(6) 2013. During the procedure, the pin fractured upon insertion. Another pin was utilized to complete the procedure with no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[19128939]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date. In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results. (note: biomet, inc. Acquired the trauma product line from depuy orthopaedics, inc. (? Depuy? ) on june 16, 2012 (? Closing date? ). Pursuant to the written agreement between biomet and depuy, biomet agreed to be responsible for regulatory reporting for events which occurred after the closing date regardless of the entity that actually manufactured the product or actually sold the product to the healthcare provider. Because the product that is the subject matter was manufactured before the closing date, please be advised that the subject product was manufactured by depuy and not biomet. ) depuy also sold the product that is the subject matter to the healthcare provider involved.
Patient Sequence No: 1, Text Type: N, H10
[21920029]
Examination of returned device found no evidence of product non-conformance. Evaluation of device found evidence that failure mode was likely due to misuse by implant being put through excessive force or over torqued, and/or not inspected for wear and disfigurement which may have prevented the use of the implant and its failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2014-00434 |
| MDR Report Key | 3579727 |
| Report Source | 07 |
| Date Received | 2014-01-16 |
| Date of Report | 2014-03-24 |
| Date of Event | 2013-12-06 |
| Date Mfgr Received | 2014-03-24 |
| Device Manufacturer Date | 2013-01-17 |
| Date Added to Maude | 2014-04-17 |
| 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 | 2014-01-16 |
| Returned To Mfg | 2014-01-29 |
| Model Number | N/A |
| Catalog Number | 841070 |
| Lot Number | 326136 |
| ID Number | N/A |
| Device Expiration Date | 2018-01-31 |
| 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 | 2014-01-16 |