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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, while using it inside the patient, the broach detaches when trying to back broach out of the canal.The procedure continued using a backup device from smith and nephew, with a surgical delay of less than 30 minutes and no injury to the patient.
Additional Manufacturer Narrative
H3, h6: it was reported that during surgery, while using the device inside the patient, the broach detaches when trying to back-broach out of the bone canal.The procedure was continued using a backup device from smith and nephew, with a surgical delay of less than 30 minutes.No injury to the patient was reported.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.Nevertheless, the batch number was reported and the production documentation review was performed.A review of the past complaints for batch a61438 revealed revealed two additional complaint devices with a similar reported failure mode.The production documentation was reviewed as well.No deviation was detected from the standard manufacturing process which could have affected the device performance.Based on the performed investigations, the reported failure mode could not be confirmed as the device was not returned for product evaluation.However, 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 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: 11568220
• Report Number: 9613369-2021-00123
• Device Sequence Number: 4206005
• Product Code: JDI
• UDI-Device Identifier: 00885556535424
• UDI-Public: 00885556535424
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/04/2021

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: A61438
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1