MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75007308
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a sl-plus/sbg/ipa mia offset adapter 40 mm is broken.It is unknown in what context this failure was observed, or if there was patient involvement.No injury was reported.
Additional Manufacturer Narrative
H3, h6: it was reported that a sl-plus mia offset adapter 40mm is broken.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed as the locking key of the adapter is bent.However, no part is broken off.Apart from that, the device shows slight signs of usage such as superficial scratches.No additional complaints for batch j72345 were reported so far.A review of the production documentation for the batch in scope did not reveal any deviation from the standard operating procedure.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.However, based on the performed investigations, the relationship between the reported event and the device was confirmed.A probable cause for the bent offset adapter locking key can only be traced to a user error by a presumed bending of the bracket, otherwise this fault pattern is not subjected to occur.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.The returned device will be discarded.

• Brand Name: SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM
• 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: 12375421
• Report Number: 9613369-2021-00350
• Device Sequence Number: 11074019
• Product Code: JDI
• UDI-Device Identifier: 07611996074895
• UDI-Public: 07611996074895
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/02/2021

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: 75007308
• Device Catalogue Number: 75007308
• Device Lot Number: J72345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1