MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP HANDLE ADAPT. 28MM TRIAL INSERT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75000650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a thr surgery, a polarcup handle adapt.28 mm trial insert broke outside the patient and no pieces fell inside.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: ¿it was reported that, during a thr surgery, a polarcup handle adapt.28mm trial insert broke outside the patient and no pieces fell inside.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.The complaint devices, used in treatment, were not returned for investigation hence the reported issue could not be confirmed.A complaint history review was performed.The production documentation could not be reviewed since the lot number was not provided.A relationship between the reported event and the device cannot be confirmed.Based on the performed investigations and the available information, the reported failure mode could not be confirmed, and it is not possible to investigate whether 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.No further actions are deemed necessary.Should additional information become available, the investigation will be reassessed.This version of the device will be monitored for similar issues.This investigation is considered closed.¿.

• Brand Name: POLARCUP HANDLE ADAPT. 28MM TRIAL INSERT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 12509644
• Report Number: 9613369-2021-00368
• Device Sequence Number: 3255546
• Product Code: LXH
• UDI-Device Identifier: 07611996116649
• UDI-Public: 07611996116649
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: 75000650
• Device Catalogue Number: 75000650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1