MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG DAA DOUBLE OFFSET ADAPTER RIGHT 80/45; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75102240
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the broach handle is loose and will not hold the trial firmly.The failure in the device was noticed during set up or inspection.The procedure was completed using the same device.No surgical delay or injury to the patient was reported.
Additional Manufacturer Narrative
It was reported that the broach handle is loose and will not hold the rasp firmly.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could not be confirmed.The device shows limited signs of use but no damage is observed on the connector site to the broach.Furthermore, the instrument has undergone a functional check.Instead of a premature separation problem, rather a slight physical resistance during removal from the gauge was detected, but still within the normal.No additional complaint with batch b71870 was reported so far.A review of the production documentation for the batch in scope did not reveal any deviation from the standard operating procedure.Based on the performed investigations, the reported failure mode could not be confirmed.The slight physical resistance during gage removal was still within the normal and the need for corrective action is not indicated.This version of the device will be monitored for similar issues.Should additional information become available, this complaint will be reassessed.This investigation is considered closed.

• Brand Name: DAA DOUBLE OFFSET ADAPTER RIGHT 80/45
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11409070
• Report Number: 9613369-2021-00091
• Device Sequence Number: 19796745
• Product Code: JDI
• UDI-Device Identifier: 00885556535394
• UDI-Public: 00885556535394
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: 75102240
• Device Catalogue Number: 75102240
• Device Lot Number: B71870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1