MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION BI-MENTUM FLEXIBLE 5 PEG DRILL DS5009; SCREW, FIXATION, BONE

Catalog Number	UNK_JSE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
We had an incident in the or with the (flexible peg drill) from the bi-mentum instruments was broken during the surgery.The surgery for the patient has been delayed.
Additional Manufacturer Narrative
Manufacturer entity d3 corrected to s.E.R.F societe detudes recherche fabrication.
Event or Problem Description
We had an incident in the or with the (flexible peg drill) from the bi-mentum instruments was broken during the surgery.The surgery for the patient has been delayed.
Additional Manufacturer Narrative
This mfr report#: 3008668801-2024-00002 was found to be a duplicate of mfr report#: 3008668801-2025-00068.All data for this patient's experience will be captured under mfr report#: 3008668801-2025-00068.This product inquiry is being closed as a duplicate.
Event or Problem Description
This mfr report#: 3008668801-2024-00002 was found to be a duplicate of mfr report#: 3008668801-2025-00068.All data for this patient's experience will be captured under mfr report#: 3008668801-2025-00068.This product inquiry is being closed as a duplicate.

• Brand Name: BI-MENTUM FLEXIBLE 5 PEG DRILL DS5009
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION; 85 avenue des bruyeres; 69150 decines-charpieu; decines NJ 69150 ; FR 69150
• Manufacturer (Section G): S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION; 85 avenue des bruyeres; 69150 decines-charpieu; decines 69150 ; FR 69150
• Manufacturer Contact: jean-denys marechal ; 85 avenue des bruyeres; 69150 decines-charpieu; decines, NJ 69150 ; FR 69150 ; 2018315000
• MDR Report Key: 20769946
• Report Number: 3008668801-2024-00002
• Device Sequence Number: 4412899
• Product Code: HWC
• UDI-Device Identifier: 03662200013203
• UDI-Public: 03662200013203
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_JSE
• Device Lot Number: 122676003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 01/24/2025; 03/26/2026
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/24/2025; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown