MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL/SBG/IPA MIA DOUBLE OFFSET ADAP.R17/13; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75004612
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an unknown surgery, the locking spring of a sl/sbg/ipa mia double offset adap.R17/13 was taken off.There was a surgical delay of 5 min was reported, and a smith and nephew backup device was available to conclude the procedure.Neither patient injury nor other complications were reported due to this event.
Additional Manufacturer Narrative
It was reported that during an unknown surgery, the locking spring of the double offset adapter 17/13mm right was taken off.There was a surgical delay of 5 min and a smith and nephew backup device was available to complete the procedure.The offset adapter device, intended for use in treatment, was returned for investigation.Upon visual inspection, the failure mode and the relationship between the reported event and the device was confirmed.The pin and locking key were not connected to the base body anymore.The device shows normal signs of usage such as small scratches and dents.Furthermore, the relevant drill hole itself looks properly machined.The protrusion at the tip of the pin is visible, which means that the pin was riveted at the time of manufacturing.The relevant dimensions of the base body and the pin were measured in the metrology department.Based on the measured dimensions, a performed tolerance analysis revealed that a proper riveting was still possible at the time of manufacturing and the pin could widen and result in a clamping due to riveting.Hence, there is no indication that the reported device failed to meet crucial manufacturing specifications upon release for distribution.A review of the production documentation did not reveal any deviation from the standard operating procedure.The device in question was manufactured in year 2009.Furthermore, no additional complaint with batch d66537 was reported so far and for the 17/13mm offset adapter right, no additional complaint with a reported loose pin was detected.As no patient injury was reported, no further clinical/medical assessment is warranted at this time.Based on the performed investigations, the probable cause for the pin loosening is attributed to a wear and tear issue through repeated use over time.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.To date, no further actions are deemed necessary.Smith and nephew will continue to monitor the device for similar issues.Should additional information become available, this complaint will be reassessed.
Event or Problem Description
It was reported that, during an unknown surgery, the locking spring of a sl/sbg/ipa mia double offset adap.R17/13 was taken off.There was a surgical delay of 5 min was reported, and a smith and nephew backup device was available to conclude the procedure.Neither patient injury nor other complications were reported due to this event.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: SL/SBG/IPA MIA DOUBLE OFFSET ADAP.R17/13
• 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: 11952784
• Report Number: 9613369-2021-00277
• Device Sequence Number: 17266090
• Product Code: JDI
• UDI-Device Identifier: 07611996085464
• UDI-Public: 07611996085464
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2021

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: 75004612
• Device Catalogue Number: 75007311
• Device Lot Number: D66537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 05/25/2021; 09/13/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/22/2021; 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1