MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/51; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75023360
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr the plastic rim of a polarcup trial insert nav 22/51 broke outside the patient.The procedure was successfully completed without significant delay using the same device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: it was reported that during a thr the plastic rim of a polarcup trial insert nav 22/51 broke outside the patient.The procedure was successfully completed without significant delay using the same device.The device use in treatment was returned for investigation.The reported failure mode could be confirmed upon visual inspection.The device is observed to be fractured.A review of the complaint history revealed two additional complaints for the batch in question.However, the batch was manufactured in 2012.Furthermore, a review of the batch record does not indicate that the device failed to match specification at the time of manufacturing.Based on the performed investigations, the reported fracture could be confirmed.The relationship between the reported event and the device was confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Normal wear and tear through repeated impaction as well as miss-use of the device are known to contribute to the reported event.Additionally, repeated steam sterilization processes could contribute to an embrittlement.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.It is unknown for how many cycles this instrument has been used.Therefore, the root cause stays undetermined after investigation.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor the device for similar issues.The returned device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT NAV 22/51
• 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: 11741252
• Report Number: 9613369-2021-00171
• Device Sequence Number: 14251121
• Product Code: LXH
• UDI-Device Identifier: 07611996112498
• UDI-Public: 07611996112498
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/04/2021

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: 75023360
• Device Catalogue Number: 75023360
• Device Lot Number: A77983
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1