MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-11 for SCHUK FLPL-SS WIRE PIST [ORIG ITEM: 140126] 140126-ENT manufactured by Osta.
[42420228]
At the time of this report, we were notified that the device will not be returned for evaluation. As a result, a determination cannot be made. If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
[42420229]
This was a therapeutic procedure. Intended procedure was removal of the entire prosthesis. Indication for the operation was bad hearing and dizziness. Operator put slight traction on the stainless steel wire in order to remove the piston. The wire came loose from the piston. The procedure was canceled, the patient was transferred to (b)(6). Piston was removed by laser surgery.
Patient Sequence No: 1, Text Type: D, B5
[45290133]
Investigation methods/details: the customer complaint of the wire separating from the prosthesis was confirmed. A review of the returned components found only the teflon portion p/n: 1171031 had been returned completely missing the wire p/n: 9220188. The dhr for ih898085 and ih899881 were both reviewed and found no abnormalities. A further review was conducted on the teflon blank assembly p/n: 1171031 mh883120 dhr as well as the receipt ticket for the raw stock material p/n: 035060 lot# 71152. No abnormalities were found in these documents either. The process was reviewed and the wire is molded to the teflon piston after an anchor is made at the end of the wire to secure it inside of the piston. Testing of existing 140126-ent lot# sd994735 product located within bartlett inventory was pull to failure to determine what force was required to remove the wire from the piston. The average strength was determined to be 0. 307 lbf. As this is a legacy item there is little historical data available to compare against. A complaint review was conducted for the last 3 years and this is the first reported failure of the wire detaching from the piston. Conclusion summary/results: summary of investigation find that the customer's complaint of a separated wire was confirmed. As this was a legacy product further analysis is being performed on wire retention capabilities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2016-00002 |
| MDR Report Key | 5568074 |
| Date Received | 2016-04-11 |
| Date of Report | 2016-05-13 |
| Date of Event | 2016-02-01 |
| Date Mfgr Received | 2016-05-13 |
| Date Added to Maude | 2016-04-11 |
| 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 | MR TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 508804-273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCHUK FLPL-SS WIRE PIST [ORIG ITEM: 140126] |
| Generic Name | WIRE PISTON |
| Product Code | ETA |
| Date Received | 2016-04-11 |
| Model Number | 140126-ENT |
| Lot Number | IH898085 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTA |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-04-11 |