MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD TENSIONER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71360020
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr surgery, the accord tensioner did not retract ((b)(4)) and the accord dual ended hex driver was stripped ((b)(4)).There were no delays and the procedure was finished with smith and nephew back up devices.The patient was not harmed.
Additional Manufacturer Narrative
H3, h6:the associated device, intended to use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.A review of complaint history did not reveal additional complaints for the listed batch for the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ACCORD TENSIONER
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11853598
• Report Number: 1020279-2021-04500
• Device Sequence Number: 3847001
• Product Code: JDG
• UDI-Device Identifier: 03596010485359
• UDI-Public: 03596010485359
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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: 71360020
• Device Catalogue Number: 71360020
• Device Lot Number: 15KM04471
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1