MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT SLOTTED 28/49; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75000665
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, while trying to relocate hip, the polar cup trial liner 49 x 28 broke inside the patient.The procedure was completed using a competitor's device.A delay of 30 min or less was reported.
Additional Manufacturer Narrative
H3, h6: it was reported that, while trying to relocate hip, the polar cup trial liner 49 x 28 (75000665) broke inside the patient.The device intended for use in treatment was not returned for investigation nor was a batch number communicated.An appropriate investigation could therefore not be conducted and the reported failure mode could not independently be confirmed.Based on the limited information provided, a thorough medical assessment could not be performed.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopedics" ag, all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the limited information provided, the root cause of the reported issue cannot be determined and 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 additional information or the device be received.

• Brand Name: POLARCUP TRIAL INSERT SLOTTED 28/49
• 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: 11684521
• Report Number: 9613369-2021-00159
• Device Sequence Number: 3095565
• Product Code: LXH
• UDI-Device Identifier: 07611996116793
• UDI-Public: 07611996116793
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: 75000665
• Device Catalogue Number: 75000665
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/07/2021
• 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