MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75004650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during total hip replacement, a polarstem stem inserter broke inside the patient.Surgery was resumed, without any delay, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: it was reported that, during total hip replacement, a polarstem stem inserter broke inside the patient.Surgery was resumed, without any delay, with a smith & nephew back-up device.The device, intended for use in treatment, was not returned for investigation.No batch number was communicated, therefore it cannot be determined whether the part met the manufacturing specification at the time of distribution.A complaint history review was conducted.The complaint is in line with the current risk management.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.Review of past corrective actions was performed.No further escalation is required.Due to insufficient information, the relationship between the reported event and the device cannot be confirmed.The root cause cannot be determined and we cannot speculate about factors which would have contributed to the reported issue.Should the part be returned for investigation, the investigation will be reopened.No further actions are deemed necessary.Smith and nephew will monitor this device for further similar issues.
Additional Manufacturer Narrative
It was reported that, during total hip replacement, a polarstem stem inserter broke inside the patient.Surgery was resumed, without any delay, with a smith & nephew back-up device.The device, intended for use in treatment, was not returned for investigation.No batch number was communicated, therefore it cannot be determined whether the part met the manufacturing specification at the time of distribution.Nevertheless, a complaint history review was conducted.The occurrence of the reported failure mode is within its expected risk management level.Furthermore, a risk management review was performed.The complaint is in line with the current risk management.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag", all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.Review of past corrective actions was performed.No further escalation is required.Due to insufficient information, the relationship between the reported event and the device cannot be confirmed.The root cause cannot be determined and we cannot speculate about factors which would have contributed to the reported issue.Should the part be returned for investigation, the investigation will be reopened.No further actions are deemed necessary.Smith and nephew will monitor this device for further similar issues.Internal complaint reference number: (b)(4).

• Brand Name: POLARSTEM STEM INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14192161
• Report Number: 9613369-2022-00225
• Device Sequence Number: 14554599
• Product Code: LXH
• UDI-Device Identifier: 07611996097573
• UDI-Public: 07611996097573
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2022

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: 75004650
• Device Catalogue Number: 75004650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 06/01/2022; 07/15/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 06/23/2022; 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown