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

Model Number	75017089
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the polarcup head/liner inserter broke.As this was noticed upon field inspection, no patient was involved.
Additional Manufacturer Narrative
H3, h6: it was reported that a polarcup head/liner inserter is broken.As this was noticed upon inspection, there was not patient involvement.The device intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted and the reported failure mode could not independently be confirmed.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 one additional complaint for the batch in question.Both complaints are reported for device damage/ fracture.However, the batch was manufactured in 2011 with a lot size of 20pcs.Based on the age of the device and its intended use, these two complaints do not indicate that the reported device failed to meet manufacturing specifications upon release for distribution.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.Based on the available information, a relationship between the reported event and the device cannot be confirmed and the root cause of the reported issue remains undetermined.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.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.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.
Additional Manufacturer Narrative
H3, h6: it was reported that a polarcup head/liner inserter is broken.As this was noticed upon inspection, there was not patient involvement.Not all parts of the head-liner insert were returned for investigation.The pendular and grip (handle) are missing.Apart from the missing parts, the device is fully functional.It is unknown if the missing parts are broken.Based on the returned parts the reported issue could not independently be confirmed.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 one additional complaint for the batch in question.Both complaints are reported for device damage/ fracture.However, the batch was manufactured in 2011 with a lot size of 20pcs.Based on the age of the device and its intended use, these two complaints do not indicate that the reported device failed to meet manufacturing specifications upon release for distribution.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 could not independently be 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 reported fracture 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.

• 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: 13389636
• Report Number: 9613369-2022-00017
• Device Sequence Number: 13881974
• Product Code: LXH
• UDI-Device Identifier: 07611996103151
• UDI-Public: 07611996103151
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2022

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: C75393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 02/25/2022; 05/03/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 02/28/2022; 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2011
• 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