MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS MINI PLATE TRAY; TRAY, SURGICAL, INSTRUMENT

Catalog Number	71174974
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the reamer broke during surgery due to pressure or torque.No injuries or delays reported.Backup device available.
Additional Manufacturer Narrative
The associated flexible shaft and the tray lids were returned and evaluated.Visual inspection of the returned devices showed that the flexible reamer shaft fractured within the shaft via mechanical overload.If sufficient offset bending or torsional forces are applied to the reamer shaft during use that exceed the strength of the material, a mechanical overload fracture can occur.The tray lids are bent, confirming the stated failure.The lids were manufactured in 2014 and the reamer shaft was manufactured in 2017.These instruments are reusable devices that can be exposed to numerous surgeries; damage from repeated use can occur.Several potential factors that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to/after each use and cleaning.Documentation review not performed for this event, as no manufacturing, packaging or labelling defects were associated with the reported failure.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate 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: EVOS MINI PLATE TRAY
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8592016
• Report Number: 1020279-2019-01819
• Device Sequence Number: 2075022
• Product Code: FSM
• UDI-Device Identifier: 00885556499993
• UDI-Public: 00885556499993
• 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,Followup
• Report Date (Section B): 07/20/2019

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: 71174974
• Device Lot Number: 17FM18879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 07/20/2019; 07/20/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 07/20/2019; 07/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1