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 Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that daa double offset adapter right 80/45 defect is located at the release button located at the distal portion of the impactor.The broach handle didn¿t ¿lock¿ onto the broach very efficiently causing the impactor to release from the embedded broach during broach removal.An s+n backup broach handle was available.No injuries or surgical delays reported.
Additional Manufacturer Narrative
It was reported that daa double offset adapter right 80/45 defect is located at the release button located at the distal portion of the impactor.The broach handle didn¿t ¿lock¿ onto the broach very efficiently causing the impactor to release from the embedded broach during broach removal.A smith and nephew backup broach handle was available.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.Furthermore, the instrument was tested with a functional test gauge.The test worked for the instrument with no negative conspicuity, meaning that the device could be connected and disconnected seamlessly from the gauge.According to the performed device history review, a rework was performed with 5 parts due to jamming.However, there is no increased risk for the manufactured devices.Otherwise, no other deviation was detected.For device 75102240 with batch in question (a61614), only one additional complaint was reported (b)(4)), but not with a comparable failure mode.Based on the performed investigations, the reported failure mode could not be confirmed and no further actions are deemed necessary.However, smith and nephew will monitor this device for further 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: 10500264
• Report Number: 9613369-2020-00170
• Device Sequence Number: 3182260
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2020

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
• Device Lot Number: A61614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 11/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1