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  

Manufacturer Narrative

Complaint reference: case-(b)(4).

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

It was reported that the broach handle is loose and will not hold the rasp firmly.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 and no damage is observed on the connector site to the broach.Furthermore, the instrument has undergone a functional check.No deviation was detected.Furthermore, the device was tested within an authentic test setup to examine the reported premature separation problem.The complained connection issue between the offset adapter and the rasp could not be reproduced after 30 hard hammer strokes.Hence, the device functioned as intended.No additional complaint with batch b70751 was reported so far.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 not be confirmed as the device functions as intended.There is no indication that the device failed to match specification at the time of manufacturing and the need for corrective actions is not indicated.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
• 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: 11444023
• MDR Text Key: 240659209
• Report Number: 9613369-2021-00103
• 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: 05/18/2021

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: B70751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1