MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS/SLR-PLUS IMPACTOR; PROSTHESIS,HIP,SEMI-CONSTRAINED,METALCERAMICPOLYMER,CEMENTEDORNON-POROUS

Model Number	110903
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the implantation of a hip prosthesis, the side superior extremity of a sl-plus/slr-plus impactor broke.Furthermore, no pieces fell into the patient.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
It was reported that, during the implantation of a hip prosthesis, the side superior extremity of a sl-plus/slr-plus impactor broke.Furthermore, no pieces fell into the patient.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed as consequence of this problem.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, the reported failure could be confirmed and the complaint sample is fractured.A review of the product documentation did not detect any deviation that could have contributed to the reported failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation has been conducted.The occurrence and severity are in line with the corresponding risk file.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number.Based on the performed investigation, the complaint could be confirmed.The root cause stays undetermined but wear and tear could have contributed to the reported failure.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.Smith&nephew will continue to monitor this device for similar issues.This investigation is considered closed.The returned complaint device will be scrapped.Internal complaint reference number: case-(b)(4).

• Brand Name: SL-PLUS/SLR-PLUS IMPACTOR
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,METALCERAMICPOLYMER,CEMENTEDORNON-POROUS
• 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: 16195518
• Report Number: 9613369-2023-00011
• Device Sequence Number: 14945121
• Product Code: LZO
• UDI-Device Identifier: 03596010036513
• UDI-Public: 03596010036513
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/23/2023

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 Model Number: 110903
• Device Catalogue Number: 75002321
• Device Lot Number: E67286
• 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: 12/21/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2018
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown