MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-06-12 for MONOFIL CRCLG TENSION/CRIMPER N/A 498022 manufactured by Biomet Orthopedics.
[16747645]
It was reported patient underwent total hip arthroplasty (b)(6) 2013 utilizing a tensioner-crimper trochanteric grip. While the surgeon was securing the cable, the crimper fractured. The fractured pieces were retrieved from the wound.
Patient Sequence No: 1, Text Type: D, B5
[17083318]
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. 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
[18565315]
Examination of returned device found no evidence of product non-conformances. Evaluation of product indicates fracture is due to the age of the product. There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, number 1 states, "surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling. Care must be taken to avoid compromising their exacting performance. To minimize damage, the following should be done: inspect the instrument case and instruments for damage when purchased and after each use and cleaning. Incompletely cleaned instruments should be re-cleaned, and those that need repair set aside for repair service or return to biomet. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2013-01925 |
| MDR Report Key | 3165789 |
| Report Source | 07 |
| Date Received | 2013-06-12 |
| Date of Report | 2013-05-16 |
| Date of Event | 2013-04-30 |
| Date Mfgr Received | 2013-08-06 |
| Device Manufacturer Date | 2005-01-26 |
| Date Added to Maude | 2013-06-12 |
| 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 | MONOFIL CRCLG TENSION/CRIMPER |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | HXQ |
| Date Received | 2013-06-12 |
| Returned To Mfg | 2013-06-03 |
| Model Number | N/A |
| Catalog Number | 498022 |
| Lot Number | 14884 |
| 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 | 2013-06-12 |