MAUDE Adverse Event Report: OSTA SCHUK FLPL-SS WIRE PIST [ORIG ITEM: 140126]; WIRE PISTON

Model Number 140126-ENT

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Dizziness (2194); Impaired Healing (2378)

Event Date 02/01/2016

Event Type  No Answer Provided  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: SCHUK FLPL-SS WIRE PIST [ORIG ITEM: 140126]
• Type of Device: WIRE PISTON
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough 01772
• Manufacturer Contact: terrence sullivan ; 136 turnpike road; southborough, MA 01772 ; 508804-273
• MDR Report Key: 5568074
• MDR Text Key: 42420228
• Report Number: 1519132-2016-00002
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK760433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 140126-ENT
• Device Lot Number: IH898085
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 70