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	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
Additional information in d4, g4, h4, h6 investigation results: it was reported that the broach handle is loose and will not hold the rasp firmly.No surgical delay or injury to the patient was reported.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 very limited signs of use but no damage is observed on the connector site to the broach.Furthermore, the instrument was tested with gauge id-nr 0723.No deviation was detected.No additional complaint with batch a60410 was reported so far.A review of the production documentation for batch a60410 did not reveal any deviation from the standard operating procedure.Based on the performed investigations, the reported failure mode could not be confirmed.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.

• 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: 11409069
• Report Number: 9613369-2021-00089
• Device Sequence Number: 3853390
• Product Code: JDI
• UDI-Device Identifier: 00885556535424
• UDI-Public: 00885556535424
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: A60410
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1