MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP REDUCER PART FOR IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75023714
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, during a thr procedure, the polarcup reducer part for impactor broke.Surgery was resumed, without any delay, with a change in surgical technique.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip replacement (thr) procedure, the polarcup reducer part for impactor broke.Surgery was resumed, without any delay, with a change in surgical technique.Patient was not harmed.A polarcup impactor handle was received for visual analysis without the polarcup reducer part for impactor, and the metal tip was noticed to be deformed.The device in question, polarcup reducer part for impacter, was not returned for visual inspection.Final product disposition is unknown.A complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.The review of the production documentation could not be conducted due to missing batch number.Furthermore, the concerning risk is covered through the smith + nephew risk management file.Due to insufficient information it is not possible to perform a review of past corrective actions.Based on available information, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Based on the available information, it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.No probable cause can be determined.The need for corrective action is not indicated.We remind to follow our document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), that all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.Smith + nephew will continue to monitor this device for similar issues.Should additional information become available, this complaint will be reopened.

• Brand Name: POLARCUP REDUCER PART FOR IMPACTOR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15058338
• Report Number: 9613369-2022-00348
• Device Sequence Number: 17339600
• Product Code: LPH
• UDI-Device Identifier: 07611996114614
• UDI-Public: 07611996114614
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 75023714
• Device Catalogue Number: 75023714
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown