MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/59; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75023364
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during surgery, it was noticed that the polarcup trial insert nav 22/59 was broken.Device outside the patient.The procedure was completed without delay using a s+n back-up device.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: it was reported that, during surgery, it was noticed that the polarcup trial insert nav 22/59 broke while impacting the cup inside patient.A piece fell in the patient, but was retrieve right after by suction and with hand.Patient was not harmed.The complaint device intended for use in treatment and the broken-off piece was returned for investigation.A visual evaluation of the returned part was conducted, and it was concluded that it was effectively broken.So, the mentioned failure mode of break is confirmed.The performed complaint history review for the complaint device revealed no previous complaints for the same batch.A review of the production documentation did not show any deviations from the standard manufacturing procedure.A review of the risk management documentation verifies the failure mode and severity of the reported issue.The ifu lists several possible adverse effects resulting from a hip arthroplasty.Previous investigations demonstrated that the performance of the device is within the risks level that are anticipated in the risk management documentation.The current design remains therefore state of the art.As part of the continuous improvement, smith + nephew is nonetheless working on a design enhancement.No further escalation is required.No clinically sufficient data was provided to perform a medical investigation.Based on the performed investigations, the reported failure mode could be confirmed.A relationship between the reported event and the device can be confirmed.No probable cause can be determined.There is no indication that the reported devices failed to meet manufacturing specifications upon release for distribution.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" 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.
Additional Manufacturer Narrative
H10: additional information in d9.H11: corrected information in b1, b2, b5, h1 and h6 (health effect - impact code).
Event or Problem Description
It was reported that, during surgery, it was noticed that the polarcup trial insert nav 22/59 broke while impacting the cup inside patient.A piece fell in the patient, but was retrieve right after by suction and with hand.The procedure was completed without delay using a s+n back-up device.Patient was not harmed.

• Brand Name: POLARCUP TRIAL INSERT NAV 22/59
• 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: 15136221
• Report Number: 9613369-2022-00463
• Device Sequence Number: 20182153
• Product Code: LXH
• UDI-Device Identifier: 07611996112535
• UDI-Public: 07611996112535
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75023364
• Device Catalogue Number: 75023364
• Device Lot Number: B72645
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 08/01/2022; 09/16/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/26/2022; 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown