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	Misconnection (1399); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the daa double offset adapter right 80/45 did not connect to the broaches, no procedure-related.
Additional Manufacturer Narrative
Results of investigation: it was reported that the daa double offset adapter right 80/45 did not connect to the broach, as the pin fell out and the hook got lost.This complaint is not procedure-related, so no patient harm was reported.The offset adapter device, intended for use in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed, as the corresponding pin and locking key (hook) of the offset adapter were not returned.The edge transition to the affected drilling hole looks slightly chamfered, which originates from the riveting process.However, the drill hole itself looks properly machined.Apart from that, the device shows normal signs of usage such as small scratches and dents.The riveting relevant 5.40 +/-0.05 mm drill diameter was measured with an optical direct light microscope.The additional 6.00 mm diameter was measured with a caliper.Both features were measured within specification.To perform a functional analysis, the returned offset adapter device was riveted again applying the standard operating procedure.A new pin and locking key were used.The riveting worked well and the device was then tested with the intended newton meter gauge (id-no: 6440).The test was passed without any conspicuity.This standard test is performed since nov.2018, which is after the assembly of the complained device.A review of the production documentation did not reveal any deviation from the standard operating procedure.Furthermore, no additional complaint with batch b67932 was reported so far and for the 80/45mm offset adapter right, no additional complaint with a reported loose pin was detected.From previous investigations, it is known that the offset adapter pin can fall out of the device when riveting was not performed or if the concerning bore hole was not properly drilled.Corrective actions and measurements have therefore been implemented in nov.2018, to prevent the occurrence of this problem in the future.However, the device in question was manufactured before these performed corrective actions and the relevant drill hole was not measured at the time of manufacturing.Based on the performed investigations, it cannot be confirmed that the 5.4mm drill hole of this device was produced out of specification leading to the pin loosening.To conclude, based on the performed investigation, there is no indication that the device failed to match specification at the time of manufacturing.The root cause of this reported issue remains unknown.Internal complaint reference number: (b)(4).

• 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: 10590808
• Report Number: 9613369-2020-00184
• Device Sequence Number: 11507507
• 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
• Report Date (Section B): 01/28/2021

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
• Operator of Device: Health Professional
• Device Model Number: 75102240
• Device Catalogue Number: 75102240
• Device Lot Number: B67932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1