MAUDE Adverse Event Report: S.B.M. SAS PULLUP INSTRUMENTATION; Ø 4.5MM CANNULATED DRILL BIT

Catalog Number	PULL000255
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) 2025 not enough elements to continue our investigations.No photos.Lot number not communicated: waiting for batch number to verify instrument manufacturing data.Instrument was discarded: not available for expertise.Waiting further information on the potential consequences for the patient and the circumstances of the incident.____________________________________________________.
Event or Problem Description
Fnconf-25-0031 incident occured in france.Event description communicated."during the ligamentoplasty procedure, the 4.5mm diameter cannulated drill (ref.(b)(6) broke in the patient's knee, with many pieces of metal to be recovered from the patient's knee joint.The instrument broke lengthwise.This incident significantly increased surgery time".
Event or Problem Description
Fnconf-25-0031.Incident occured in france.Event description communicated."during the ligamentoplasty procedure, the 4.5mm diameter cannulated drill (ref.Pull000255) broke in the patient's knee, with many pieces of metal to be recovered from the patient's knee joint.The instrument broke lengthwise.This incident significantly increased surgery time".
Additional Manufacturer Narrative
20 february 2025: not enough elements to continue our investigations.No photos.Lot number not communicated: waiting for batch number to verify instrument manufacturing data.Instrument was discarded: not available for expertise.Waiting further information on the potential consequences for the patient and the circumstances of the incident.27 may 2025: additional information / result of analysis.Circumstances of the event: "the drill bit exploded in 5 pieces without entering the femur".Lot identification after verification: lot 232764.Device not available for analysis / no photos.Instrument on deposit since january 2024.Review of manufacturing history: drill manufacturing is not considered to be the cause of the failure.Additional analyses: *tests to verify the cutting performance of ligafix instrumentation cutting tools: results in compliance.*check of the minimum thickness at the bottom of the flute after cutting a drill from the same batch / result compliant (>or= 0.35mm for a specification of 0.3mm min).Possible causes identified: hypothesis n°1: breakage due to impact or contact of one of the cutting edges with a stainless-steel pin, shaver, sight or other instrument.Hypothesis 2: drill blunted during previous operations, requiring the surgeon to apply thrust to advance the drill into the bone.The application of pushing forces results in bending deformation of the drill, which could cause several or a combination of damage.The investigation findings do not lead to a clear conclusion about the cause.No corrective or preventive action implemented.

• Brand Name: PULLUP INSTRUMENTATION
• Common Device Name: Ø 4.5MM CANNULATED DRILL BIT
• Manufacturer (Section D): S.B.M. SAS; zi du monge; lourdes, 65100 ; FR 65100
• Manufacturer (Section G): S.B.M. SAS; zi du monge; lourdes, 65100 ; FR 65100
• Manufacturer Contact: regine estaun ; zi du monge; lourdes, 65100 ; FR 65100
• MDR Report Key: 21431608
• Report Number: 3004549189-2025-00003
• Device Sequence Number: 4361183
• Product Code: HTW
• UDI-Device Identifier: 03760154006163
• UDI-Public: 03760154006163
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: PULL000255
• Device Lot Number: 232764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 81 KG