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

Model Number	75023714
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up for a thr, the tip of the polarcup impactor handle was noticed to be bent from over use.Surgery was performed, without any delay, with a back-up device instead.As this was noticed during set up, patient was not yet involved.Upon visual analysis, a polarcup reducer part for impactor was received and was noticed to be fractured.
Additional Manufacturer Narrative
H6: it was reported that, during set up for a total hip replacement surgery (thr), the tip of the polarcup impactor handle (case-(b)(4)) was noticed to be bent from over use.Surgery was performed, without any delay, with a back-up device instead.As this was noticed during set up, patient was not yet involved.Upon visual analysis, a polarcup reducer part for impactor was received and was noticed to be fractured.The device intended for use in treatment has been returned for investigation.Upon visual inspection, the reported failure mode of the product could be confirmed.The device is heavily scratched, bent and additionally fractured/deformed into two (2) pieces.Due to the scratches, the batch number is not readable anymore.The product documentation review could not be performed due to unreadable batch number.Due to insufficient information it is not possible to perform a review of past corrective actions.A review of the risk management documentation verifies the failure mode and severity of the reported issue.A complaint history review was performed.The current complaint is in line with the complaint review on part level.Based on the performed investigations, the reported failure mode can be confirmed.Normal wear and tear through repeated usage is known to contribute to the reported event.Based on the available information, it is not possible to investigate whether the reported device met manufacturing specification upon release for distribution.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopedics ag" all devices must be inspected and controlled for proper functioning after cleaning/disinfection.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint is considered closed.

• Brand Name: POLARCUP REDUCER PART FOR IMPACTOR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 15283804
• Report Number: 9613369-2022-00482
• Device Sequence Number: 16761037
• Product Code: LZO
• 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): 09/22/2022

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
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN: 75023345 / LOT: UNKNOWN.
• Patient Sex: Unknown