MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0DEG 36MM TRIAL 52MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71365252
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a thr surgery, a r3 0 degree 36mm inner diameter trial acetabular liner 52mm outer diameter was inserted, and when it was removed, the surgeon saw a piece of green plastic that broke off from it.The piece was retrieved with ease.Surgery was performed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the associated device was not returned for evaluation and the reported event could not be confirmed.A review of complaint history revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.An historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable, damage may occur during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.The contribution of the device to the reported event could not be corroborated.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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: R3 0DEG 36MM TRIAL 52MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13180970
• Report Number: 1020279-2022-00105
• Device Sequence Number: 17244454
• Product Code: LXH
• UDI-Device Identifier: 03596010599544
• UDI-Public: 03596010599544
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71365252
• Device Catalogue Number: 71365252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown