MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-05-15 for GLENOSPHERE FORCEPS N/A 406236 manufactured by Biomet Orthopedics.
[18812143]
It was reported patient underwent reverse shoulder procedure on (b)(6) 2013. Post operative radiographs showed a piece of the instrument had fractured and remained in the patient. Subsequently, patient underwent procedure on (b)(6) 2013 to remove the fractured piece.
Patient Sequence No: 1, Text Type: D, B5
[19061192]
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. There are warnings in the package insert that state that this type of event can occur: under precautions it lists, "intraoperative fracture or breaking of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments that have experienced extensive use or excessive force are susceptible to fracture. Surgical instruments should only be used for their intended purpose. Biomet recommends that all instruments be regularly inspected for wear and disfigurement. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2013-01518 |
| MDR Report Key | 3114391 |
| Report Source | 07 |
| Date Received | 2013-05-15 |
| Date of Report | 2013-04-18 |
| Date of Event | 2013-04-17 |
| Date Mfgr Received | 2013-04-18 |
| Device Manufacturer Date | 2011-07-13 |
| Date Added to Maude | 2013-05-15 |
| 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 | GLENOSPHERE FORCEPS |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | HYA |
| Date Received | 2013-05-15 |
| Model Number | N/A |
| Catalog Number | 406236 |
| Lot Number | 248070 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-05-15 |