MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-08-27 for G7 SCREW 6.5MM X 40MM N/A 010001001 manufactured by Biomet Orthopedics.
[24202824]
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. Examination of returned device found no evidence of product non-conformance. Evaluation of device found evidence that failure mode was most likely due to misalignment when drilling or positioning the g7 screw hole. However, the root cause of the event could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[24202825]
It was reported that patient underwent a total hip arthroplasty on (b)(6) 2015. During the procedure, the screw would not fully seat into the acetabular cup. Competitor screws were utilized to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[26270747]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-03836 |
| MDR Report Key | 5034268 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-08-27 |
| Date of Report | 2015-08-27 |
| Date of Event | 2015-06-03 |
| Date Mfgr Received | 2015-08-27 |
| Device Manufacturer Date | 2014-10-13 |
| Date Added to Maude | 2015-08-27 |
| 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 | 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 SCREW 6.5MM X 40MM |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LKD |
| Date Received | 2015-08-27 |
| Returned To Mfg | 2015-07-22 |
| Model Number | N/A |
| Catalog Number | 010001001 |
| Lot Number | 3446892 |
| 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. Required No Informationntervention | 2015-08-27 |