MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-11-07 for ORTHOSORB 1PN/3PK 40X1.3MM KIT N/A 841052 manufactured by Biomet Orthopedics.
[5064282]
It was reported that during a bunionectomy on (b)(6), 2014, the surgeon had the pin prepared and was plunging the pin into the patient when the pin split vertically. Another orthosorb pin was used successfully and patient did not retain any foreign bodies.
Patient Sequence No: 1, Text Type: D, B5
[12463854]
Current information is insufficient to permit a conclusion as to the cause of the event. A review of device history records has been requested. 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
[32693838]
Examination of returned device found no evidence of product non-conformance. During the evaluation, it was noted the root cause of the event was most likely due to misuse or misalignment of the resorbable pin causing the pin to split during insertion, and/or the device was not inspected for wear and disfigurement prior to use, which may have prevented the use of the instrument and its failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2014-08561 |
| MDR Report Key | 4237874 |
| Report Source | 07 |
| Date Received | 2014-11-07 |
| Date of Report | 2015-01-08 |
| Date of Event | 2014-10-10 |
| Date Mfgr Received | 2015-01-08 |
| Device Manufacturer Date | 2014-05-02 |
| Date Added to Maude | 2014-11-07 |
| 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. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| 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 1PN/3PK 40X1.3MM KIT |
| Generic Name | PIN, FIXATION |
| Product Code | OVZ |
| Date Received | 2014-11-07 |
| Returned To Mfg | 2014-11-05 |
| Model Number | N/A |
| Catalog Number | 841052 |
| Lot Number | 482983 |
| ID Number | N/A |
| Device Expiration Date | 2018-10-31 |
| 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 | 1. Required No Informationntervention | 2014-11-07 |