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

Model Number	75023745
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a thr surgery, the polarstem fin stabilizer for 21000300 device snapped during use.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: d4 (expiration date), h4 (manufacturing date), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that during a total hip replacement surgery, the polarstem stem inserter device snapped during use.Patient was not injured as consequence of this problem.The complaint device has not been completely returned.A visual evaluation of the returned part was conducted, and it was concluded that the holding pin of the inner rod to the knob broke.The knob shows signs of use and the thread of the rod is damaged.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause of the event can be attributed to an unintended or off label use.The polarstem stem inserter (75004650) must not be hit, and it shall be used for the implantation of cemented polarstems only.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag", all devices must be inspected and controlled for proper functioning after cleaning/disinfection.The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be discarded.Corrected data: b5 (narrative updated), d1 (brand name), d2a/d2b (product code & common device name), d4 (catalog number, lot number & udi number), d9 (device was returned to manufacturer), g4 (device has no 510k number associated).
Event or Problem Description
It was reported that during a thr surgery, the polarstem stem inserter device snapped during use.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.

• 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: 16448716
• Report Number: 9613369-2023-00120
• Device Sequence Number: 19736329
• Product Code: LXH
• UDI-Device Identifier: 07611996097573
• UDI-Public: 07611996097573
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (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): 05/18/2023
• 2 Devices were Involved in the Event: 1 2

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: 75023745
• Device Catalogue Number: 75004650
• Device Lot Number: F72898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown