MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/55; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75023362
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).
Event or Problem Description
It was reported that, a polarcup trial insert nav 22/55 is broken.It is unknown at what stage of the surgery the incident occurred.However, it is known that a sn back-up device was available and that there was no delay in surgery.No harm to the patient or further complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: it was reported that, a polarcup trial insert nav 22/55 is broken.It is unknown at what stage of the surgery the incident occurred.However, it is known that a sn back-up device was available and that there was no delay in surgery.No harm to the patient or further complications reported.The complaint device, used in treatment, was returned for investigation and the reported failure mode could be confirmed upon visual inspection.The complaint device was found fractured.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 no additional complaint for the batch in question.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 the performed investigations, 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 22/55
• 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: 14672545
• Report Number: 9613369-2022-00285
• Device Sequence Number: 14630788
• Product Code: LXH
• UDI-Device Identifier: 07611996112511
• UDI-Public: 07611996112511
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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: 75023362
• Device Catalogue Number: 75023362
• Device Lot Number: A75252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 06/12/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown