MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-10-21 for G7 STR INSERTER THREADED SHAFT N/A 110003452 manufactured by Biomet Orthopedics.
[28828506]
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. There are warnings in the package insert that state that this type of event can occur: "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling. " 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
[28828507]
It was reported patient underwent an initial total hip arthroplasty on (b)(6) 2015. During the procedure, the threads broke off of the insertion handle during impaction and the threads remained in the cup. The cup was removed and another cup was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[32662170]
Examination of returned device found no evidence of product non-conformance. Evaluation found the threads had fractured in the cup as stated in the complaint. The returned fractured instrument shows failure via fracture consistent with bending overload.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-04377 |
| MDR Report Key | 5165265 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-10-21 |
| Date of Report | 2015-11-12 |
| Date of Event | 2015-09-28 |
| Date Mfgr Received | 2015-11-12 |
| Device Manufacturer Date | 2013-10-14 |
| Date Added to Maude | 2015-10-21 |
| 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 | G7 STR INSERTER THREADED SHAFT |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LKD |
| Date Received | 2015-10-21 |
| Returned To Mfg | 2015-10-13 |
| Model Number | N/A |
| Catalog Number | 110003452 |
| Lot Number | 364817 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-10-21 |