MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP REDUCER PART FOR IMPACTOR

Model Number	75023344
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a thr surgery, a polarcup reducer part for impactor broke inside patient during impaction.All pieces where retrieved by hand.The procedure was completed, with a delay less than 30 min, using a s+n back-up device.Patient was not harmed.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: it was reported that, during a thr surgery, a polarcup reducer part for impactor broke inside patient during impaction.All pieces were retrieved by hand.The procedure was completed, with a delay less than 30 min, using a s+n back-up device.Patient was not harmed.The complaint device, used in treatment, was returned for investigation.The reported event could be confirmed upon visual inspection, the complaint device was found broken into two pieces.A review of the production documentation revealed no deviations from the standard manufacturing process.The complaint history review did not show any further complaints for the affected lot reporting a similar event.The risk management review was performed, the severity and the failure mode are covered through our risk management.The ifu 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.Corrective actions have been previously initiated to reduce the occurrence of this issue.The reported batch was produced before the implementation of the corrective action.No further escalation is required.The medical information was reviewed.Based on the information provided, the root cause of the reported impactor breakage cannot be definitively concluded.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.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.The need for corrective action is not indicated.Smith & nephew will continue to monitor this device for similar issues.The returned device will be discarded.Internal complaint reference number: (b)(4).

• Brand Name: POLARCUP REDUCER PART FOR IMPACTOR
• Common Device Name: IMPACTOR
• 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: 14519789
• Report Number: 9613369-2022-00267
• Device Sequence Number: 6530812
• Product Code: HWA
• UDI-Device Identifier: 07611996112337
• UDI-Public: 07611996112337
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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: 75023344
• Device Catalogue Number: 75023344
• Device Lot Number: A77811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2012
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown