MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/61; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75023714
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tha, a polarcup reducer part for impactor broke while impacting the cup.No piece fell inside of the patient's incision.Procedure was completed with the same device.Surgery was not delayed.Patient was not harmed.
Additional Manufacturer Narrative
Additional information: b5 d1, d2, d4, h4.
Event or Problem Description
It was reported that, during a tha, a polarcup trial insert nav 22/61 broke while impacting the cup.No piece fell inside of the patient's incision.Procedure was completed with the same device.Surgery was not delayed.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a tha, a polarcup reducer part for impactor broke while impacting the cup.No piece fell inside of the patient's incision.Procedure was completed with the same device.Surgery was not delayed.Patient was not harmed.The complaint device, used in treatment, was not returned for investigation and the reported failure mode could not be confirmed upon visual inspection.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.A review of the batch record revealed no deviations from the standard manufacturing process.A review of the complaint history revealed one additional complaint for the batch in question reporting a fractured device.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Corrective actions have been previously initiated to reduce the occurrence of this issue.The reported batch was produced before the implementation of the corrective action.No further escalation is required.Based on available information, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.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.Normal wear and tear through repeated use is known to contribute to the reported event.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.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should the device be received.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a tha, a trial insert nav.61/22 broke while impacting the cup.No piece fell inside of the patient's incision.Procedure was completed with the same device.Surgery was not delayed.Patient was not harmed.The complaint device, used in treatment, was returned for investigation and the reported failure mode could be confirmed upon visual inspection.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.A review of the batch record revealed no deviations from the standard manufacturing process.A review of the complaint history revealed one additional complaint for the batch in question reporting a fractured device.A review of the risk management documentation verifies the failure mode and severity of the reported issue.No prior escalation actions are related to the reported issue.Based on available information, the reported failure mode could be confirmed.A relationship between the reported event and the device can be confirmed.The reported device met manufacturing specifications upon release for distribution.No probable cause can be determined.Normal wear and tear through repeated use is known to contribute to the reported event.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.This version of the device will be monitored for similar issues.This investigation is considered closed.The complaint device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT NAV 22/61
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 14720259
• Report Number: 9613369-2022-00309
• Device Sequence Number: 5562365
• Product Code: LXH
• UDI-Device Identifier: 07611996112542
• UDI-Public: 07611996112542
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/31/2022
• 2 Devices were Involved in the Event: 1 2

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: 75023365
• Device Lot Number: A52848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 07/15/2022; 08/12/2022; 08/30/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 07/18/2022; 08/30/2022; 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2012
• 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