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 Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint: case-(b)(4).
Event or Problem Description
It was reported that the locking mechanism between handle and broach is loosening.Fault in device was noticed during use.The procedure was completed with the same device.A delay of 30 min or less was reported.No patient harm was reported.
Additional Manufacturer Narrative
It was reported that the locking mechanism between handle and broach is loose.The fault in device was noticed during use.The procedure was completed with the same device.A delay of 30 min or less and no patient harm was reported.The complaint device, used in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could not be confirmed.The returned device shows limited signs of use such as small dents and scratches, but no damage is observed on the connector site to the broach.Furthermore, the instrument was tested with a gauge and no deviation was detected.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.No additional complaint was detected for the batch in question.For the article in scope, three additional complaints with a similar reported failure mode were detected.In the past, there were already comparable complaints of 60/25mm offset adapters right or left with a reported premature separation problem.A detailed functional evaluation was performed at this time with the returned devices.However, the complained connection issue between the offset adapter and the rasp could not be reproduced.Hence, the failure mode cannot be confirmed, as there was no problem found.S+n will continue to monitor complaints of the 60/25mm offset adapters for similar issues.The returned device will be discarded.

• 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: 11195417
• Report Number: 9613369-2021-00042
• Device Sequence Number: 10938587
• Product Code: JDI
• UDI-Device Identifier: 00885556535394
• UDI-Public: 00885556535394
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1