MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-03-27 for BIOMET BIOLOGICS MINI CTR BAL N/A 800-0505 manufactured by Biomet Orthopedics.
[4247159]
It was reported patient underwent an initial procedure on (b)(6) 2014. While preparing for the procedure, the gps ii platelet machine made a popping noise and the balance fractured. A delay of over 30 minutes occurred during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[11591082]
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. The following sections could not be completed with the limited information provided. Expiration date - unknown. Manufacture date? Unknown. 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.
Patient Sequence No: 1, Text Type: N, H10
[32631937]
This follow-up report is being filed to relay correct product identification. Examination of returned device found no evidence of product non-conformance. During the evaluation, it was noted the origin of the fracture suggests the counterbalance was not in the correct carrier or not fully seated in the correct carrier.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2014-02133 |
| MDR Report Key | 3702833 |
| Report Source | 07 |
| Date Received | 2014-03-27 |
| Date of Report | 2014-09-02 |
| Date of Event | 2014-02-05 |
| Date Mfgr Received | 2014-09-02 |
| Date Added to Maude | 2014-03-27 |
| 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 | BIOMET BIOLOGICS MINI CTR BAL |
| Generic Name | SUPPLIES, BLOOD-BANK |
| Product Code | KSS |
| Date Received | 2014-03-27 |
| Returned To Mfg | 2014-02-28 |
| Model Number | N/A |
| Catalog Number | 800-0505 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| 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. Hospitalization; 2. Required No Informationntervention | 2014-03-27 |