MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0DEG 36MM TRIAL 54MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71365254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the device was damaged.Broke during use, all pieces accounted for.No delay or injury reported.Procedure finished with same device.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned trial indicated that a portion of the outer profile fractured off.The fractured portion was not returned.This device was manufactured in 2014, showing signs of wear/ use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 0DEG 36MM TRIAL 54MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8200752
• Report Number: 1020279-2018-02919
• Device Sequence Number: 1557252
• Product Code: LXH
• UDI-Device Identifier: 03596010599551
• UDI-Public: 03596010599551
• 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): 01/16/2019

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: 71365254
• Device Lot Number: 14JDS0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1