MAUDE Adverse Event Report: S.B.M. SAS COMPOSITCP 60; SCREW, FIXATION, BONE

Catalog Number	905261
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an initial procedure, the screw fractured while performing implantation.Pieces of the screw remains in the patient's bone tunnel.The correct surgical technique was used.No other complications or impacts were reported due to this malfunction.Attempts have been made, and no further information has been provided.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMPOSITCP 60
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): S.B.M. SAS; zi du monge 12- 14 rue; francis jammes; lourdes
• MDR Report Key: 21724512
• Report Number: 0001825034-2025-00888
• Device Sequence Number: 9437159
• Product Code: HWC
• UDI-Device Identifier: 03760154006712
• UDI-Public: (01)03760154006712(17)260201(10)230593
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K090994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Catalogue Number: 905261
• Device Lot Number: 230593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Male