MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG DAA DOUBLE OFFSET ADAPTER RIGHT 80/45; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 75102240

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2020

Event Type  malfunction  

Event Description

It was reported that the daa double offset adapter right 80/45.No procedure-related.

Manufacturer Narrative

It was reported that a daa double offset adapter right 80/45 and the daa double offset adapter left 80/45 were found with some rust starting to form.This case is not procedure-related and therefore, no injuries or surgical delays were reported.The devices, intended for use in treatment, were returned for investigation.Upon visual inspection, the reported failure mode could not be confirmed.The devices show signs of moderate wear, such as small dents and scratches, but no rust could be detected.The instrument was also tested with gauge id-nr 0723 but no deviation was detected.The function test worked for the instrument with no negative conspicuity.A review of the batch record revealed no deviations from the standard manufacturing process.Furthermore, a review of the complaint history revealed no other complaints for the batches in question.Based on the performed investigation, the root cause of the reported issue remains undetermined.There is no indication that the device failed to match specification at the time of manufacturing.The need for corrective action is therefore not indicated.Smith and nephew recommends all reusable instruments to be routinely inspected for wear and damage and to be replaced as necessary.Smith + nephew will continue to monitor these devices for similar issues.The returned devices will be discarded.

• Brand Name: DAA DOUBLE OFFSET ADAPTER RIGHT 80/45
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10857382
• MDR Text Key: 219177430
• Report Number: 9613369-2020-00240
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 00885556535394
• UDI-Public: 00885556535394
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• 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: A59149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1