MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-06-04 for ORTHOSORB 1 PIN 50X1.3MM KIT N/A 841070 manufactured by Biomet Trauma.
[3524350]
It was reported that patient underwent a bunionectomy procedure utilizing a resorbable pin on (b)(6) 2013. During the procedure, the pin fractured upon insertion in the patient and the surgeon removed pieces of the pin. Another pin was available to complete the procedure without delay.
Patient Sequence No: 1, Text Type: D, B5
[10793337]
Review of device history records show that lot released with no recorded anomaly or deviation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2013-01784 |
| MDR Report Key | 3144243 |
| Report Source | 07 |
| Date Received | 2013-06-04 |
| Date of Report | 2013-05-07 |
| Date of Event | 2013-04-07 |
| Date Mfgr Received | 2013-05-07 |
| Device Manufacturer Date | 2012-12-07 |
| Date Added to Maude | 2013-06-04 |
| 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. ANGIE DICKSON |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST 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 | 2013-06-04 |
| Model Number | N/A |
| Catalog Number | 841070 |
| Lot Number | 307074 |
| ID Number | N/A |
| Device Expiration Date | 2017-11-30 |
| 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. Hospitalization; 2. Required No Informationntervention | 2013-06-04 |