MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT SLOTTED 28/47; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75000664
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a thr surgery, the polarcup trial insert slotted 28/47 was broken.The procedure was completed, with a delay (less than 30 minutes) , using a s+n back-up device.No patient injuries and no other complications were reported.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a thr surgery, the polarcup trial insert slotted 28/47 (art.No.75000664 / unknown lot number) was broken.The procedure was completed, with a delay (less than 30 minutes), using a smith+nephew back-up device.No patient injuries and no other complications were reported.The complaint device, used in treatment, was not returned for investigation.The lot number was not known, the production documentation could not be performed.The complaint history review was performed.The risk management review was performed, the severity and the failure mode are covered through our risk management.The ifu (lit.No.12.23 ed 05/16) requires "before use, the functionality of surgical instruments should be checked." all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on the performed investigations, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Based on the available information 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 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.

• Brand Name: POLARCUP TRIAL INSERT SLOTTED 28/47
• 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: 11855852
• Report Number: 9613369-2021-00258
• Device Sequence Number: 14293444
• Product Code: LXH
• UDI-Device Identifier: 07611996116786
• UDI-Public: 07611996116786
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 75000664
• Device Catalogue Number: 75000664
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention