MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION RH606 5 HYPE BROACH SIZE 5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	RA90611085
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon encountered a problem with a set of hype rasps, rasp number 5 rh 606 5, which got stuck in the patient's femur, resulting in a risk of femur fracture and longer operating times, with a high risk of infection.(this pi is for the event being reported for event date march 31, 2025).
Additional Manufacturer Narrative
Reported event: an event regarding non-functionnal (the rasp was stuck got stuck in the patient's femur) involving a rh606 5 hype broach size 5 was reported.Conclusions: the reported device is an serf product.In the absence of product returns for technical investigation and feedback on the product lot code for documentary investigation, the cause cannot be established." corrective action/preventive action: no action is required.
Event or Problem Description
No new information.

• Brand Name: RH606 5 HYPE BROACH SIZE 5
• 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: 21923188
• Report Number: 3008668801-2025-00097
• Device Sequence Number: 8713631
• Product Code: LXH
• UDI-Device Identifier: 03662200020539
• UDI-Public: 03662200020539
• 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
• 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: RA90611085
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 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: 75 YR
• Patient Sex: Male