MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/57; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	75023363
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
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, a piece of an unknown trial insert broke off during reduction.The broken piece was retrieved.No delay was reported, but it is unknown how the procedure was completed.No injuries were reported.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip replacement surgery, a piece of the polarcup trial insert nav 22/57 broke off during reduction.The broken piece was retrieved from the patient via suction and kocher.No injuries were reported.The complaint device was returned for investigation.A visual evaluation of the device was conducted, and it was concluded that the complaint device returned in two pieces.One part of the complaint device fractured off.Furthermore, there are signs of wear such as scratches and dents.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and 4 additional similar complaints for the same product number over the past 12 months with similar failure mode.Previous investigations demonstrated that the performance of the device is within the risks level that are anticipated in the risk management documentation.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 reported event remains undetermined.Considering the performed visual inspection, it is suspected that the mentioned device failure arose from a ¿wear and tear" issue.Normal wear and tear are known to contribute to the reported event.Additionally, repeated steam sterilization processes could contribute to an embrittlement.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.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.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip replacement surgery, a piece of the polarcup trial insert nav 22/57 broke off during reduction.The broken piece was retrieved.No delay was reported, but it is unknown how the procedure was completed.No injuries were reported.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.No batch number was communicated so the production history review was not possible.Due to an unknown batch number, the review of historical complaints was performed on product number basis only, revealing 3 additional complaints over the past 12 months with similar failure mode.Due to insufficient information it is not possible to perform a review of past corrective actions.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The performed investigation does not lead to an accurately determined cause.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to indicate 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.There is no need for further actions because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.
Event or Problem Description
It was reported that, during a thr surgery, a piece of the polarcup trial insert nav 22/57 broke off during reduction.The broken piece was retrieved from the patient via suction and kocher.The surgery was completed, without any delay, with a s+n back-up device.No injuries were reported.
Event or Problem Description
It was reported that, during a thr surgery, a piece of the polarcup trial insert nav 22/57 broke off during reduction.The broken piece was retrieved.No delay was reported, but it is unknown how the procedure was completed.No injuries were reported.
Additional Manufacturer Narrative
H10 ¿ additional information.D4 ¿ unique identifier (udi) # h11 - corrected data.B5 ¿ describe event or problem.D1- brand name.D3- manufacturer name, city and state: this report was inadvertently submitted under manufacturer report number 1020279.Correct manufacturer report number is 9613369.D4 ¿ catalog number.G¿ contact office - manufacturing site.

• Brand Name: POLARCUP TRIAL INSERT NAV 22/57
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18378227
• Report Number: 1020279-2023-02553
• Device Sequence Number: 12662703
• Product Code: LXH
• UDI-Device Identifier: 07611996112528
• UDI-Public: 07611996112528
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/25/2024

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: 75023363
• Device Lot Number: A63523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/08/2024; 01/16/2024; 02/12/2024; 03/22/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/08/2024; 01/17/2024; 02/23/2024; 03/25/2024
• 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