MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-10-16 for G7 STR MONOBLOCK SHELL INSRTR N/A 110003450 manufactured by Biomet Orthopedics.
[28495032]
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. 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. There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, it states,? Surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.?
Patient Sequence No: 1, Text Type: N, H10
[28495033]
It was reported that patient underwent a hip arthroplasty on (b)(6) 2015. During the procedure, the surgeon used a mallet to impact the handle on the strike plate. Upon impaction, the threads of the screw hole were damaged. In an attempt to remove the handle, the handle fractured. It is unknown if pieces had to be retrieved from patient.
Patient Sequence No: 1, Text Type: D, B5
[30874470]
Upon reassessment of the reported event, it was determined to be not reportable. The initial report was forwarded in error and should be voided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-04325 |
| MDR Report Key | 5156186 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-10-16 |
| Date of Report | 2017-11-06 |
| Date of Event | 2015-09-16 |
| Date Mfgr Received | 2015-09-21 |
| Device Manufacturer Date | 2013-09-23 |
| Date Added to Maude | 2015-10-16 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| 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 MONOBLOCK SHELL INSRTR |
| Generic Name | INSTRUMENT, MANUAL |
| Product Code | LKD |
| Date Received | 2015-10-16 |
| Returned To Mfg | 2015-10-16 |
| Model Number | N/A |
| Catalog Number | 110003450 |
| Lot Number | 724340 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-10-16 |