MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION FT 49 REAMER 49; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	RA90370249
Medical Device Problem Codes	Mechanics Altered (2984); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
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
It was reported via serf reference: (b)(4)."the surgeon asked us to change the 2 complete sets of novae burs on (b)(6) 2025.According to the surgeon, the 2 sets of burs were worn and no longer milled properly, which he felt prevented him from obtaining satisfactory acetabular support.We had him change sizes 47 to 53 of the 2 sets of burs on (b)(6) 2025.
Additional Manufacturer Narrative
Correction of product code in section d2b.Correction of common device name in section d2a.Reported event: an event regarding a non-functional ft 49 reamer 49 was reported.Conclusion: technical investigation: the product was not returned, making the technical investigation impossible.Nevertheless this complaint is similar to 6 others related complaints.Conclusion of the technical investigation on the similar complaints is applicable to this one.The most likely causes identified ise: manual sharpening of teeth.It was noted that the teeth are sharpened manually at the supplier's premises; some teeth are sharpened more aggressively than others, impacting ease of cutting.Corrective action/preventive action: a capa was opened with 2 actions: addition of a new control at the subcontractor level to ensure the aggresiveness specification of the reamers.Opening of a change control to add a cnc (computer numerical machine) machine for the manufacturing of the reamers.
Event or Problem Description
No new infomation.

• Brand Name: FT 49 REAMER 49
• 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, NJ 69150 ; FR 69150 ; 2018315000
• MDR Report Key: 21545620
• Report Number: 3008668801-2025-00087
• Device Sequence Number: 8050079
• Product Code: HWE
• UDI-Device Identifier: 03662200013043
• UDI-Public: 03662200013043
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: RA90370249
• Device Lot Number: 129006005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/30/2026
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Male