MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REAMER DOME 55MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71362755
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after thr procedure it was noticed that the reamer was shedding metal inside the patient.No delay.The procedure was finished using the same device.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, after the surgery, the reamers were shedding.Per email communication, the metal shavings were removed from the patient using "standard surgical instruments from hospital trays." it was further reported that there was no patient harm or surgical delay.Based on the information provided, no further clinical assessment is warranted.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 the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.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: REAMER DOME 55MM
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10293459
• Report Number: 1020279-2020-03332
• Device Sequence Number: 19035331
• Product Code: JDG
• UDI-Device Identifier: 03596010456939
• UDI-Public: 03596010456939
• Combination Product (Y/N): N
• 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): 08/20/2021

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: 71362755
• Device Catalogue Number: 71362755
• Device Lot Number: 16GM04782
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/18/2020
• Supplement Report FDA Received Date: 08/20/2021
• 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