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

Model Number	75102237
Medical Device Problem Codes	Difficult to Insert (1316); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the handle is not locking onto the broaches.The issue was noticed during surgery.The procedure was completed using the same device.A delay of 30 min or less was reported.
Additional Manufacturer Narrative
It was reported that the handle is not locking onto the broaches.The issue was noticed during surgery and the procedure was completed using the same device.The device, used in treatment, was not returned for investigation.A visual inspection could therefore not be performed.Based on the performed complaint history review, no additional complaint was detected for the batch in question.Furthermore, the production documentation was reviewed and no deviations from the standard manufacturing procedure were detected.Based on the performed investigations, the failure mode of the reported issue could not be confirmed and the root cause of the reported problem remains unknown.There is no indication that the device failed to match specification at the time of manufacturing.The need for corrective action is therefore not indicated.Nevertheless, smith and nephew will continue to monitor the device for similar issues.This investigation is considered closed.The complaint will be reopened should the device be received.

• Brand Name: DAA DOUBLE OFFSET ADAPTER LEFT 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: 11654380
• Report Number: 9613369-2021-00153
• Device Sequence Number: 3495016
• Product Code: JDI
• UDI-Device Identifier: 00885556535424
• UDI-Public: 00885556535424
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: 75102237
• Device Catalogue Number: 75102237
• Device Lot Number: A61327
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1