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

Model Number	75004650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tha, the polarstem stem inserter broke.It is unknown if any fragment fell inside of the patient.Surgery was completed freehandedly with a delay of less than 30 min.Patient was not harmed.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip replacement, the polarstem stem inserter broke.The device, intended for use in treatment, was not returned for investigation.Therefore, a product evaluation is not possible.The production history of the device was reviewed.There are no indications that the device failed to match specification at the time of manufacturing.A complaint history review was conducted.The complaint is in line with the current risk management.Review of past corrective actions was performed.No further escalation is required.It must be noted, that this stem inserter shall only be used to implant the cemented version of the polarstem.The device should never be impacted to insert the stem.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: (b)(4).

• Brand Name: POLARSTEM STEM 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: 13975337
• Report Number: 9613369-2022-00071
• Device Sequence Number: 4788958
• Product Code: LXH
• UDI-Device Identifier: 07611996097573
• UDI-Public: 07611996097573
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 75004650
• Device Catalogue Number: 75004650
• Device Lot Number: E68602
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2019
• 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