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	07/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr procedure, a polarstem stem inserter broke.The incident occurred with the instrument outside the patient.A smith and nephew backup device was used instead to complete the procedure, no delay reported.Patient not harmed.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: it was reported that during a total hip arthroplasty, a polarstem stem inserter broke.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.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
H3, h6: it was reported that during a total hip arthroplasty, a polarstem stem inserter broke.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.It was assessed that the risk level in the corresponding risk file is still adequate.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.

• 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
• MDR Report Key: 12305469
• Report Number: 9613369-2021-00342
• Device Sequence Number: 11716810
• Product Code: LXH
• UDI-Device Identifier: 07611996097573
• UDI-Public: 07611996097573
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 10/05/2021; 10/25/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 10/06/2021; 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1