MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PLUS SL MIA DBL OFFSET ADAPT. RT 60/25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75004613
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during thr surgery, the connection post for strike plate of a polarstem broach handle snapped off outside the patient.No significant surgical delay was reported as a smith and nephew back up device was available.Neither patient injury nor other complications were reported.
Additional Manufacturer Narrative
H3, h6: it was reported that, during total hip replacement surgery, the connection post for strike plate of a polarstem broach handle snapped off outside the patient.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.A review of the production documentation for the batch in scope did not reveal any deviation from the standard operating procedure.No additional complaint with batch b51295 was reported so far.As the part was not returned for investigation, the reported failure mode could not be confirmed and a relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Based on the conducted investigation, the root cause could not be determined conclusively and the need for corrective actions is not indicated.According to the document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.Instruments should only be used in their original condition (lit.No.12.23 ed.05/16).Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.Should more information become available, the investigation will be reopened.No further actions are deemend necessary at the time.Smith+nephew will continue to monitor for similar issues.

• Brand Name: PLUS SL MIA DBL OFFSET ADAPT. RT 60/25MM
• 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: 11821071
• Report Number: 9613369-2021-00212
• Device Sequence Number: 3747564
• Product Code: JDI
• UDI-Device Identifier: 07611996085471
• UDI-Public: 07611996085471
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 75004613
• Device Catalogue Number: 75004613
• Device Lot Number: B51295
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1