MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION RH606 6 HYPE BROACH SIZE 6; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	RA90611086
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon has encountered problems with hype rasps where rasp 6 was stuck in the patient's femur resulting in a risk of femur fracture and an extension of the operating time with a high risk of infection.
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
No new information.
Additional Manufacturer Narrative
Correction of reportability awareness date in section g3.Typo mistake of the reportability awareness date in the previous report 3008668801-2025-00092 follow-up 1.
Additional Manufacturer Narrative
Reported event : an event regarding non-functional (the rasp was stuck got stuck in the patient's femur) involving a rh606 6 hype broach size 6 was reported.Conclusions : in accordance with procedure, serf made at least three follow-up attempts to obtain information about the device and to request its return.The batch number was not provided, and the product was not received.Documentary investigation not feasible: insufficient information to identify the device.Technical investigation not feasible: the device was not received by serf.Conclusion: the most probable cause cannot be established.Corrective action/preventive action: no action is required.
Event or Problem Description
No new information.

• Brand Name: RH606 6 HYPE BROACH SIZE 6
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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 69150 ; FR 69150 ; 472056010
• MDR Report Key: 21779603
• Report Number: 3008668801-2025-00092
• Device Sequence Number: 8663932
• Product Code: LXH
• UDI-Device Identifier: 03662200020546
• UDI-Public: 03662200020546
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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: RA90611086
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 03/31/2026
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/03/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male