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

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2021

Event Type  malfunction  

Event Description

It was reported that during thr, the daa double offset adapter right 80/45 handle mechanism would repeatedly release the broach during the removal, causing the surgeon to reattach multiple times while removing the broaches.The procedure was finished without delay using the same device no patient injury or other complications were reported.

Manufacturer Narrative

H6: it was reported that during total hip replacement surgery, the daa double offset adapter right 80/45 handle mechanism would repeatedly release the broach during the removal, causing the surgeon to reattach multiple times while removing the broaches.The device, intended for use in treatment, was returned for investigation.A visual inspection was performed.The device shows limited signs of use such as small dents and scratches.No damage is observed on the connector site to the broach.Furthermore, the instrument was tested with a gauge where no deviation was detected.For batch a58223, no additional complaint was reported so far.A review of the production documentation for the batch in scope does not indicate any manufacturing process error.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.However, based on the performed investigations, the relationship between the reported event and the device was confirmed.As a contributing factor, 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.No further actions are deemed necessary.The device will be discarded.

• Brand Name: DAA DOUBLE OFFSET ADAPTER RIGHT 80/45
• Type of Device: 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: 11793937
• MDR Text Key: 250414590
• Report Number: 9613369-2021-00188
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00885556535394
• UDI-Public: 00885556535394
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

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
• Device Operator: Health Professional
• Device Model Number: 75102240
• Device Catalogue Number: 75102240
• Device Lot Number: A58223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 07/16/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1