MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP HEAD/LINER INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75017089
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, the plastic part of the polarcup head/liner inserter cracked off.As this was notice during set up or inspection, not patient was involved.
Additional Manufacturer Narrative
D4: expiration date added h4: manufacture date added h3, h6: it was reported that, the plastic part of the polarcup head/liner inserter cracked off.As this was notice during set up or inspection, not patient was involved.The device use in treatment was returned for investigation.A visual inspection confirmed the reported issue.One of the two ribs of the linear guide is observed to be fractured.During normal use, the linear guide should not be exposed to forces that could cause such a fracture.The cause for the observed fracture stays undetermined.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.A review of the complaint history revealed seven additional complaints reported for the batch in question.However, a batch size of 1000 pieces was produced.The additional complaints are therefore not considered to indicate a manufacturing issue related to this batch.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Review of past corrective actions was performed.No further escalation is required.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 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.Based on the conducted investigation the root cause for the fracture of the linear guide could not be identified and stays undetermined.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.Internal complaint reference: (b)(4).

• Brand Name: POLARCUP HEAD/LINER INSERTER
• 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: 13540344
• Report Number: 9613369-2022-00032
• Device Sequence Number: 4162209
• Product Code: LXH
• UDI-Device Identifier: 07611996103151
• UDI-Public: 07611996103151
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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: 75017089
• Device Catalogue Number: 75017089
• Device Lot Number: 10F71731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• 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