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 2016-08-04 for GLENOSPHERE FORCEPS N/A 406236 manufactured by Biomet Orthopedics.
[51196896]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show the lot released with no recorded anomaly or deviation. The following sections could not be completed with the limited information provided. There are warnings in the package insert that state that this type of event can occur. Under care and handling 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. Care must be taken to avoid compromising their exacting performance. " device requested, not yet received.
Patient Sequence No: 1, Text Type: N, H10
[51196897]
The folded tip of the forceps was fractured upon return from the facility. There was no patient involvement or delay in a procedure reported.
Patient Sequence No: 1, Text Type: D, B5
[55156657]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Examination of returned device found no evidence of product non-conformance. Review of the device confirmed the reported condition as the tip of one of the forceps arms was chipped. Product most likely failed due to bending overload while implanting the glenosphere; however, a conclusive root cause of the event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2016-02869 |
| MDR Report Key | 5846082 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-08-04 |
| Date of Report | 2016-08-16 |
| Date Mfgr Received | 2016-08-16 |
| Device Manufacturer Date | 2011-07-21 |
| Date Added to Maude | 2016-08-04 |
| 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 | GLENOSPHERE FORCEPS |
| Generic Name | FORCEPS, WIRE HOLDING |
| Product Code | HYA |
| Date Received | 2016-08-04 |
| Returned To Mfg | 2016-08-16 |
| Model Number | N/A |
| Catalog Number | 406236 |
| Lot Number | 248130 |
| 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 | 2016-08-04 |