MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-22 for ZIMMER FLEXIBLE REAMER 5MM manufactured by Zimmer Biomet.
[98089452]
Patient was undergoing a total elbow arthroplasty with the zimmer 5mm flexible reamer being used on the patient's ulna. The head of the reamer fractured and became lodged in the patient's ulna. The fractured tip was unable to be removed. The risk of removal was greater than allowing the fractured tip to be retained. The 5mm reamer is one piece in a set of progressively larger reamers. Zimmer intramedullary reaming system. The reamers have a silver colored shaft with a gold colored bit/augur at the end. There is a channel for a guide-wire to pass through the reamer. It appears that the augur bit fractured and broke from the shaft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074727 |
| MDR Report Key | 7212099 |
| Date Received | 2018-01-22 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-10-16 |
| Date Added to Maude | 2018-01-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZIMMER FLEXIBLE REAMER 5MM |
| Generic Name | ZIMMER FLEXIBLE REAMER 5MM |
| Product Code | GFG |
| Date Received | 2018-01-22 |
| ID Number | PRODUCT # 00-2228-005-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-22 |