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

Catalog Number	75004650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that during a thr surgery, two (2) polarstem stem inserter broke while trying to insert the polarstem.No pieces fell inside the wound.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that during a total hip replacement (thr) surgery, two (2) polarstem stem inserter broke while trying to insert the polarstem.No pieces fell inside the wound.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.The devices, intended for use in treatment, were not returned.No visual evaluation could be performed.As the batch numbers are unknown, the respective production records could not be reviewed.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Due to insufficient information it is not possible to perform a review of past corrective actions.Due to an unknown batch number, the review of historical complaints was performed on product number basis only, revealing 13 additional complaints over the past 12 months with similar failure mode.Based on the available information and the performed investigation, the reported failure mode could not be confirmed, and it is not possible to investigate whether the reported devices met manufacturing specifications upon release for distribution.A relationship between the reported event and the devices cannot be confirmed.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.Should the devices or additional information be received, the complaint will be reopened.Smith and nephew will continue to monitor this article for similar issues.This investigation is considered closed.

• 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: 18029110
• Report Number: 9613369-2023-00206
• Device Sequence Number: 20352139
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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 Catalogue Number: 75004650
• Device Lot Number: UNKNOWN
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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