MAUDE Adverse Event Report: BRM EXTREMITIES S.R.L. BRM TOOL SCREWS INSTRUMENT; CANNULATED SCREWDRIVER

Model Number	SLIM CANNULATED SCREWDRIVER HEX 2.5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record for lot 0831/25 was conducted.All manufacturing specifications, including material certificates were found to be within requirements.No similar trends of failure have been identified for this lot to date.During the final stages of screw positioning, the device may have encountered unprepared or unexpectedly dense bone tissue.The resulting mechanical resistance (torsional stress) likely exceeded the structural integrity of the screwdriver tip, leading to the fracture.At this time, based on the information currently available, a definitive root cause cannot be established.
Event or Problem Description
On (b)(6) 2026, a surgical procedure was performed in colombia.During the procedure, a 4.0 diameter screw was implanted.Initially, the necessary drilling and countersinking were performed.Subsequently, the 4.0 screw was inserted.Upon completion of the screw insertion, a cracking sound was heard.Upon removal of the hexagonal cannulated screwdriver, it was found that the final portion was fractured.Intraoperative radiographic assessment was performed to locate eventual fractured metallic fragments.No fragment was visible in the soft tissues and the screw was implanted in the correct position.Since the screw was already fully inserted into the bone, the surgeon decided to complete the procedure without further issues.

• Brand Name: BRM TOOL SCREWS INSTRUMENT
• Common Device Name: CANNULATED SCREWDRIVER
• Manufacturer (Section D): BRM EXTREMITIES S.R.L.; via privata ai campi, 7; civate, lc 23862 ; IT 23862
• Manufacturer (Section G): BRM EXTREMITIES S.R.L.; via privata ai campi, 7; civate, lc 23862 ; IT 23862
• Manufacturer Contact: lisa fazzini ; via privata ai campi, 7; civate, lc 23862 ; IT 23862
• MDR Report Key: 24983428
• Report Number: 3016669046-2026-00002
• Device Sequence Number: 21445438
• Product Code: LXH
• UDI-Device Identifier: 08053782780143
• UDI-Public: (01)08053782780143(10)0831/25(11)250626
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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
• Device Model Number: SLIM CANNULATED SCREWDRIVER HEX 2.5
• Device Catalogue Number: STVI2ES025S
• Device Lot Number: 0831/25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 50 KG