MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-24 for DORNHOFFER TI PORP 2MM 70141014 manufactured by Gyrus Acmi, Inc.
[143454732]
The device was returned to olympus for evaluation. A visual and microscopic inspection was performed on the returned device and found the unit was broken and with two detached pieces. There was evidence of tool markings on the side of the cradle. Also, overstress at the breaking point of the unit shaft displaying a curve bent at the proximal end. There were no foreign materials noted on the unit. Based on the evaluation, the exact cause of the reported event could not be conclusively determined; however, there were evidence of tools usages applied on the unit and likely causing the shaft to break as a result of mishandling. The original equipment manufacturer (oem) performed a review of the dhr for the subject device and lot number without showing any non-conformities or deviations regarding the related issue.
Patient Sequence No: 1, Text Type: N, H10
[143454733]
Olympus was informed that while implanting the device, the metal prongs separated from the plastic portion and had to retrieved from the patient? S ear. The intended procedure was completed with a similar device. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00770 |
| MDR Report Key | 8547417 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-03-28 |
| Date Added to Maude | 2019-04-24 |
| 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. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNHOFFER TI PORP 2MM |
| Generic Name | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENTETB |
| Product Code | ETB |
| Date Received | 2019-04-24 |
| Returned To Mfg | 2019-04-10 |
| Model Number | 70141014 |
| Lot Number | NC800019 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-24 |