MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENSION GAUGE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	00578907100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the gap checker broke.Delay of less than 30min reported.No injury or back up reported.
Additional Manufacturer Narrative
The associated zuk gap check was returned and evaluated.A visual inspection of the returned device revealed a small portion of the part has fractured off.The broken piece is not returned.The device shows signs of extreme wear/use.The manufacturing date of the device is unknown.Our investigation did not determine a specific cause of the stated failure.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TENSION GAUGE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8197921
• Report Number: 1020279-2018-02905
• Device Sequence Number: 19275025
• Product Code: MDM
• UDI-Device Identifier: 00885556618868
• UDI-Public: 00885556618868
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00578907100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1