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

Model Number	75004650
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr surgery, the headed end of a polarstem stem inserter has sheared off.The procedure was completed, without delay, using the same device.Patient was not harmed.
Additional Manufacturer Narrative
It was reported that, during a total hip replacement surgery, the headed end of a polarstem stem inserter has sheared off.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.One additional complaint with batch c77510 was reported so far.However, in this case, the failure mode was attributed to an off label use.A review of the production documentation for the batch in scope did not reveal any deviation from the standard operating procedure.As the part was not returned for investigation, the reported failure mode could not be confirmed and a relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause could not be determined conclusively and the need for corrective actions is not indicated.According to the 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.Instruments should only be used in their original condition (lit.No.12.23 ed.05/16).Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.Should more information become available, the investigation will be reopened.No further actions are deemed necessary at the time.Smith+nephew will continue to monitor this device for 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: 11872739
• Report Number: 9613369-2021-00261
• Device Sequence Number: 3269290
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 05/06/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1