MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/53; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75023361
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that he plastic on trial chipped of during use, while inside the patient.Case finished with no issues.No surgical delay or injury to the patient was reported.
Additional Manufacturer Narrative
Complaint reference: (b)(4).
Additional Manufacturer Narrative
Investigation results: it was reported that the plastic on a polarcup trial insert nav 22/53 (75023361) chipped of during use, while inside the patient.Case finished with no issues.The device used in treatment was not returned for investigation nor was a batch number communicated.An appropriate investigation could therefore not be conducted and the reported issue could not independently be confirmed.The requested documentation and current patient status were not provided for inclusion in the medical investigation.Based on the information provided with no alleged patient harm or surgical delay, no further patient impact would be anticipated and no further medical assessment is warranted at this time.The reported failure mode is covered by the current risk management and risk analysis.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.Based on available information the root cause for the reported issue cannot be determined.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.The complaint will be reopened should the complained device or additional information be received.
Additional Manufacturer Narrative
Investigation results: it was reported that the plastic on a polarcup trial insert nav 22/53 (75023361) chipped of during use, while inside the patient.Case finished with no issues.The complaint device, used in treatment, was returned for complaint investigation.The reported failure mode could be confirmed upon visual inspection.Two out of eight segments are observed to be broken at the top end.A review of the batch record revealed no deviations from the standard manufacturing process.A review of the complaint history revealed no additional complaint for the batch in question.There is no indication that the device did not meet specifications at the time of manufacturing.Based on the conducted investigation, the root cause for the device breakage could not be determined conclusively and stays undetermined.No further actions are deemed necessary.Nevertheless, smith + nephew will continue to monitor this device for similar issues.The returned device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT NAV 22/53
• 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: 11218199
• Report Number: 9613369-2021-00054
• Device Sequence Number: 16984248
• Product Code: LXH
• UDI-Device Identifier: 07611996112504
• UDI-Public: 07611996112504
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75023361
• Device Catalogue Number: 75023361
• Device Lot Number: A75256
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/19/2021; 05/20/2011
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 02/24/2021; 04/15/2021
• 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: Required Intervention