MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 9.0MM FIXED ENDCUTTING RMR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71118226
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, while reaming for a humeral nail, the 9.0mm fixed endcutting reamer shaft broke.All pieces were collected.Procedure concluded with a back-up device from smith and nephew, without a delay or an injury.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.The clinical/medical team concluded, per report, all of the broken pieces were retrieved from the patient.The procedure was completed using a back-up without delay.Since no adverse events are being reported due to the reported event and no further harm is anticipated, no further medical assessment is warranted.A visual inspection confirmed the 9.0mm fixed endcutting rmr is bent.The device shows significant signs of wear/usage.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 products failed to meet any product specifications at the time of manufacture.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 risk management file revealed this failure mode was previously identified.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 9.0MM FIXED ENDCUTTING RMR
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10557824
• Report Number: 1020279-2020-04704
• Device Sequence Number: 3538262
• Product Code: JDG
• UDI-Device Identifier: 03596010436597
• UDI-Public: 03596010436597
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2021

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: 71118226
• Device Catalogue Number: 71118226
• Device Lot Number: 08DM00627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2020
• Initial Date Received by Manufacturer: 08/23/2020
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 09/19/2020
• Supplement Report FDA Received Date: 04/10/2021
• 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