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
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr procedure and outside the patient, the daa double offset adapter right 80/45 did not hold broach properly.Surgery was finished with an s+n backup device.No injuries or surgical delays reported.
Additional Manufacturer Narrative
H6- device evaluation code: 2900.
Additional Manufacturer Narrative
It was reported that during a thr procedure and outside the patient, the daa double offset adapter right 80/45 did not hold the broach properly.Surgery was finished with an s+n backup device.No injuries or surgical delays reported.The device, used in treatment, was returned for investigation.Upon visual, slight signs of use such as dents and scratches over the whole device were detected.Apart from that, no abnormality at the connection site to the rasp could be detected.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.The root cause of this reported complaint is therefore a design issue.This version of the device will be monitored for similar issues.The returned device will be discarded.

• Brand Name: DAA DOUBLE OFFSET ADAPTER RIGHT 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: 10590765
• Report Number: 9613369-2020-00183
• Device Sequence Number: 2977360
• Product Code: JDI
• UDI-Device Identifier: 00885556535394
• UDI-Public: 00885556535394
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 11/09/2020

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: 75102240
• Device Catalogue Number: 75102240
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 08/31/2020; 11/06/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 09/28/2020; 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1