MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION MF 5 E FLEXIBLE PEG DRILL DIA 5; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	RA90470022
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4): serf rc-24-0382 the drill broken while in use in patient.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Corrected data: correction of product code in section d2b, correction of common device name in section d2a, section g4: product is 510k exempt, section h3 device evaluated by the manufacturer: yes.Investigation conclusion: technical investigation: after observation of the received product, the investigation concludes with a most likely hypothesis of use of the flexible in "unscrewing" mode with reversal of the direction of rotation of the motor.The devicer must only be used in the "screwing" direction.As part of the technical investigation, the surgical technique and the ifu were reviewed.Neither document indicates that the instrument should be used only in screwing mode.Documentary investigation: the last step of the manufacturing order was carried out on 07/31/2020.Consequently, the concerned device has exceeded the useful life estimated in the ifu "eca200100018-f ifu instruments dps".The investigation associated with the manufacturing of the product will therefore not be extended.Review of complaints on the mf 5 e reference: this is the first occurrence concerning a breakage of this device.1 complaint received in 2022 ((b)(4)) received on this device reporting that the device was twisted.Overall conclusion: the most likely cause is missing information in the accompanying documents leading to a use defect (d09) in addition, the device has exceeded its estimated lifetime (d1105).Following this complaint, a corrective action was opened under reference (b)(4).A change control was opened ((b)(4)) to update the ifu and the surgical technique to add the following instruction: ¿mf 5 e shall be used exclusively in "screwing" orientation, never in "unscrewing" orientation.¿.

• Brand Name: MF 5 E FLEXIBLE PEG DRILL DIA 5
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION; 85 avenue des bruyeres; 69150 decines-charpieu; decines 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, FL 69150 ; FR 69150 ; 9546280700
• MDR Report Key: 21230323
• Report Number: 3008668801-2025-00068
• Device Sequence Number: 18253444
• Product Code: HWE
• UDI-Device Identifier: 03662200013203
• UDI-Public: 03662200013203
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K181744
• 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
• Report Date (Section B): 02/25/2026

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: RA90470022
• Device Lot Number: 122676003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2020
• 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 Sex: Unknown