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
H3, h6: 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.A visual inspection was performed.The device shows very limited signs of use and no damage is observed on the connector site to the broach.Furthermore, the instrument was tested with a gauge whereby no deviation was detected.One additional complaint was reported for batch a58530.However, this complaint has another reported failure mode as the complained device.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 be confirmed.Previous investigations demonstrated that under specific circumstances the double offset adapter 80/45 may disconnect from the rasp during backslapping.An optimized design of the device has been released in order to reduce the occurrence of this issue.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: 11196301
• Report Number: 9613369-2021-00047
• Device Sequence Number: 703575
• 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): 05/10/2021

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: A58530
• 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: 12/29/2020
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1