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

Catalog Number	00578907100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tension gauge broke during the range of motion check during the case.All pieces were recovered.A backup device was not needed.No delay or injury reported.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured and all pieces were not returned.The device exhibits signs of extensive wear/usage.Plastics are vulnerable to brittle fractures due to over loading in a bending manner.A crack may have initiated during use or due to the heating and cooling associated with autoclaving.The device batch information was not provided or present on the device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TENSION GAUGE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8519571
• Report Number: 1020279-2019-01591
• Device Sequence Number: 1612250
• Product Code: LXH
• UDI-Device Identifier: 00885556618868
• UDI-Public: 00885556618868
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/12/2019

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: 04/08/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1