MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT SLOTTED 28/51; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75000666
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during thr surgery, one polarcup trial insert slotted 28/51 broke while being used outside the patient.It is unknown how the procedure was finished.However, there was no delay.Patient was not harmed as a consequence of this problem.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip replacement surgery, one (1) polarcup trial insert slotted 28/51 broke while being used outside the patient.The complaint device intended for use in treatment was returned for investigation.A visual evaluation of the returned device was conducted, and it showed that one piece was broken off.It was concluded that the complaint device was fractured.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The performed complaint history review for the alleged device revealed no other similar complaints for the same batch, and the complaint history review performed on product number level over the previous 12 months revealed 1 additional complaint with a related failure mode, but the additional case did not lead to precisely determined root cause.Previous investigations demonstrated that the performance of the device is within the risks level that are anticipated in the risk management documentation.As part of the continuous improvement, smith + nephew is working on a design enhancement.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The investigation process do not lead to a clear conclusion.The reported failure mode can be confirmed, but the root cause stays undetermined after investigation.Normal wear and tear are known to contribute to the reported event.To date, further actions are not deemed necessary.There is no objective indication that the reported device failed to meet manufacturing specifications upon release for distribution.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.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT SLOTTED 28/51
• 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: 16048235
• Report Number: 9613369-2022-00605
• Device Sequence Number: 20442293
• Product Code: LXH
• UDI-Device Identifier: 07611996116809
• UDI-Public: 07611996116809
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 01/16/2023

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: 75000666
• Device Catalogue Number: 75000666
• Device Lot Number: A76987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/26/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2011
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown