MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REAMER DOME 53MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71362753
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	Injury (2348); 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 after 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.Therefore, product analysis could not be performed at this time.Photo provided by the customer could not confirm the stated failure.A medical investigation was conducted and confirms it was reported 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 complaint history did not reveal additional complaints for the listed batch.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 risk management file revealed this failure mode was previously identified.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.G1 mdr reporting contact name and address and phone number.

• Brand Name: REAMER DOME 53MM
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10293476
• Report Number: 1020279-2020-03336
• Device Sequence Number: 811754
• Product Code: JDG
• UDI-Device Identifier: 03596010456915
• UDI-Public: 03596010456915
• 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): 05/26/2021

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: 71362753
• Device Catalogue Number: 71362753
• Device Lot Number: 16GM04106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 07/18/2020
• Supplement Report FDA Received Date: 05/26/2021
• 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