MAUDE Adverse Event Report: S.B.M. SAS RETROTECH_PULLUP INSTRUMENTATION; RETROTECH® RETROGRADE DRILL

Catalog Number	LIG9000294
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
February 04, 2026, verification of manufacturing data: the batch complies with expected specifications.Initial observations of the recovered product: the drill bit is broken - the general condition of the instrument indicates a large number of sterilizations/uses.No clinical consequences to the patient - no additional surgery - the patient did not retain any part of the defective device - delay in surgery over than 30mn (stipulated in the incident report).Waiting for further information for analyzing the incident and assessing the recovered instrument.
Event or Problem Description
Fnconf (b)(4) incident occured in vietnam.Complaint description: "the drill bit of retro drill guide system broke during bone tunnel drilling in an acl reconstruction surgery".Additional information / circumstance: "the surgeon was using a 9mm drill bit to prepare a tunnel for a 9mm tendon graft.During the drilling process, the drill bit fractured".

• Brand Name: RETROTECH_PULLUP INSTRUMENTATION
• Common Device Name: RETROTECH® RETROGRADE DRILL
• 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: 24258540
• Report Number: 3004549189-2026-00003
• Device Sequence Number: 15470100
• Product Code: HTW
• UDI-Device Identifier: 03760304680045
• UDI-Public: 03760304680045
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: LIG9000294
• Device Lot Number: 200909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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: 31 YR
• Patient Sex: Male