MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6; OSTEOTOME

Catalog Number	75002165
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during a thr, the tip of a cs/csl/geradschaft-plus extract.Screw m6 broke off in the stem.There was no delay and the procedure was finished using a smith & nephew back up.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was returned for evaluation.Upon visual evaluation, the distal threaded tip is fractured off.Furthermore, signs of wear such as scratches and dents are visible on the device.Apart from that no further defects were observed.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.A review of past corrective actions was performed.No further escalation is required.A review of the product 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 five additional similar complaints for the same product number over the past prior 12 months of the reporting date of this event with similar a failure mode.Based on the available information and the performed investigation, the reported failure mode could be confirmed.The exact root cause of the reported event remains undetermined.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.The need for further actions is not indicated.This investigation is considered as closed.Smith and nephew will continue to monitor this device for similar issues.The returned complaint sample will be scrapped.Additional information: d9.

• Brand Name: CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6
• Common Device Name: OSTEOTOME
• 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: 21688197
• Report Number: 9613369-2025-00055
• Device Sequence Number: 15666009
• Product Code: HWM
• UDI-Device Identifier: 07611996056563
• UDI-Public: 7611996056563
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 75002165
• Device Lot Number: C76022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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