MAUDE Adverse Event Report: S.B.M. SAS COMPOSITCP 4.5MM TWO #2 BBAND; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE/SPORTS MEDICINE

Catalog Number	110026108
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while the surgeon was implanting the implant, the implant fractured.The surgeon was able to remove the proximal portion of the implant, but the distal portion was well fixed in the patient's bone.The surgeon decided to leave the portion remaining in the patient's bone.There is no plan to revise the patient to remove the foreign body at this time.Attempt has been made to obtain additional information.No additional information has been received at this time.

• Brand Name: COMPOSITCP 4.5MM TWO #2 BBAND
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE/SPORTS MEDICINE
• Manufacturer (Section D): S.B.M. SAS; zi du monge; lourdes, 65100 ; FR 65100
• MDR Report Key: 21942655
• Report Number: 0001825034-2025-01210
• Device Sequence Number: 9056440
• Product Code: MAI
• UDI-Device Identifier: 03760154008242
• UDI-Public: (01)03760154008242(17)260201(10)230746
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K180960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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: 110026108
• Device Lot Number: 230746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown