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

Device Problem Premature Separation (4045)

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

Event Date 02/08/2021

Event Type  malfunction  

Event 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.

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
• 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: 11409069
• MDR Text Key: 234680474
• Report Number: 9613369-2021-00089
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00885556535424
• UDI-Public: 00885556535424
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 75102237
• Device Catalogue Number: 75102237
• Device Lot Number: A60410
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1