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

Model Number	71365256
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tha surgery, the plastic tab of the r3 0 degrees 36mm trial 56mm broke off internal to patient.The procedure was finished using a smith and nephew back up device, with no surgical delay.The broken piece was recovered and there was no injury to patient.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirmed a piece is broken off the r3 0deg 36mm trial 56mm.The broken piece was returned with the device.The device shows significant signs of wear/usage.A medical investigation was conducted and confirms this case reports the plastic tab on the trial implant broke of inside the patient.Per complaint details, the broken piece was recovered and the procedure was successfully completed without a delay, using a backup device.No patient injury or other complications were reported.Therefore, since no patient harm is being alleged, no further assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.We consider this investigation closed.

• Brand Name: R3 0DEG 36MM TRIAL 56MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10272579
• Report Number: 1020279-2020-03188
• Device Sequence Number: 14299024
• Product Code: LXH
• UDI-Device Identifier: 03596010599568
• UDI-Public: 03596010599568
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71365256
• Device Catalogue Number: 71365256
• Device Lot Number: 12MDS0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention