MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-03 for UNKNOWN ORTHOSORB TRAUMA N/A manufactured by Biomet Trauma.
[59037930]
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[59037931]
It was reported during multiple cases, the pin fractured during use. The surgeon reported difficulty finding fractured pieces in the patient and some pieces may be retained due to the color of the pin. Some cases have been completed using another device. No further information has been provided regarding patient outcomes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-04372 |
| MDR Report Key | 6075466 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-03 |
| Date of Report | 2016-10-06 |
| Date Mfgr Received | 2016-10-06 |
| Date Added to Maude | 2016-11-03 |
| 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 | 3 |
| 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 | UNKNOWN ORTHOSORB TRAUMA |
| Generic Name | PIN, FIXATION |
| Product Code | OVZ |
| Date Received | 2016-11-03 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET TRAUMA |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2016-11-03 |