MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-01-13 for ORTHOSORB LS 1.3MM TPRD PN KIT N/A 110010745 manufactured by Biomet Trauma.
[35816446]
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. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 3 states,? Bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing.?
Patient Sequence No: 1, Text Type: N, H10
[35816447]
It was reported that patient underwent a foot procedure on (b)(6) 2015. During the procedure, a pin crumbled when inserted into the patient's foot. All pieces were retrieved from the patient, a k-wire was used, and an additional hole was created to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-00149 |
| MDR Report Key | 5364318 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-01-13 |
| Date of Report | 2015-12-31 |
| Date of Event | 2015-12-28 |
| Date Mfgr Received | 2015-12-31 |
| Device Manufacturer Date | 2015-05-04 |
| Date Added to Maude | 2016-01-13 |
| 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 | ORTHOSORB LS 1.3MM TPRD PN KIT |
| Generic Name | PIN, FIXATION |
| Product Code | OVZ |
| Date Received | 2016-01-13 |
| Model Number | N/A |
| Catalog Number | 110010745 |
| Lot Number | 768100 |
| ID Number | N/A |
| 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 | 2016-01-13 |