MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0DEG 36MM TRIAL 56MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71365256
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during thr the tabs in the outside of trial broke off from usage.No delay or injury reported.A back up device was available.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.Two of the attachment tabs on the side of the trial liner fractured off and were not returned.The plastic t-handle fractured in half at the shaft connection point and only one half of the handle was returned.The devices were manufactured in 2007 and 2009 and exhibit signs of extensive wear/ usage.The t-handle fracture surface shows multiple regions of crack initiation.This was likely caused by bending, torsional, or impact mechanical overload.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 0DEG 36MM TRIAL 56MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8351499
• Report Number: 1020279-2019-00698
• Device Sequence Number: 11326053
• Product Code: LXH
• UDI-Device Identifier: 03596010599568
• UDI-Public: 03596010599568
• 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): 04/03/2019

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: 71365256
• Device Lot Number: 09DDS101
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1