MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-19 for HYBRID GLENOID INSTRUMENT DRILL GUIDE ALIGNMENT PIN N/A 406180 manufactured by Biomet Orthopedics.
[16049472]
It was reported patient underwent total shoulder arthroplasty on (b)(6), 2012. Subsequently, during the post-operative x-rays, it was discovered the hybrid glenoid drill guide alignment pin was left inside of the patient.
Patient Sequence No: 1, Text Type: D, B5
[16241947]
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 for related implants that states that this type of event can occur: under precautions it states, "intraoperative fracture or breaking of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments, which 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. " the user facility was notified of the event on (b)(6), 2012. In the event that the user facility submits a medwatch report, biomet will forward a copy to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00876 |
| MDR Report Key | 2621058 |
| Report Source | 07 |
| Date Received | 2012-06-19 |
| Date of Report | 2012-05-25 |
| Date of Event | 2012-05-21 |
| Date Mfgr Received | 2012-05-25 |
| Device Manufacturer Date | 2012-04-21 |
| Date Added to Maude | 2012-06-19 |
| 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. ANGELA DICKSON |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| 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 | HYBRID GLENOID INSTRUMENT DRILL GUIDE ALIGNMENT PIN |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | IQO |
| Date Received | 2012-06-19 |
| Model Number | N/A |
| Catalog Number | 406180 |
| Lot Number | 304100 |
| 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. Deathisabilit | 2012-06-19 |