MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CUP IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	E0015212-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: case (b)(4).
Event or Problem Description
It was reported that the handle of the r3 cup impactor broke.It is unknown whether the event happened during surgery and if there was patient involvement.Additional details have not ben provided at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation.Therefore, the product analysis and the reported event could not be confirmed at this time.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.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.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 CUP IMPACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11479756
• Report Number: 1020279-2021-02151
• Device Sequence Number: 19690716
• Product Code: LXH
• UDI-Device Identifier: 00885556662977
• UDI-Public: 00885556662977
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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 Model Number: E0015212-1
• Device Catalogue Number: E0015212-1
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1