MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION MP010 MINIMALLY INVASIVE GRIPPER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	RA90460129
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
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
Serf reported receiving results of a clinical study.During an intervention, the mp010 gripper handle broke.
Additional Manufacturer Narrative
Manufacturer entity d3 corrected to s.E.R.F societe detudes recherche fabrication.
Event or Problem Description
Serf reported receiving results of a clinical study.During an intervention, the mp010 gripper handle broke.
Event or Problem Description
Update of the executive summary: during a procedure, the mp010 gripper handle reportedly broke.A metal object was found in the surgical incision.
Additional Manufacturer Narrative
Correction of product code in section d2b.Correction of product common device name in section d2a.Addition of lot code in section d4.Product returned to manufacturer in section d9.Date of return of the product in section d9.Reported event : an event regarding crack/facture involving a mp010 minimally invasive gripper shaft was reported.The reported device is an serf product.Investigation conclusions: documentary investigation: production order: (b)(4).Final inspection date: 12/19/2018.No non-compliant products recorded.The manufacturer's estimated lifespan (see current instructions) is 81 uses, or a service life of 3 years.This device has therefore exceeded its estimated lifespan.Technical investigation: the visual inspection reveals a break in the weld/spring.The document review indicates that the instrument has exceeded the useful life estimated in the instructions.The technical investigation will therefore not be further investigated.In conclusion, the device has exceeded its useful life.

• Brand Name: MP010 MINIMALLY INVASIVE GRIPPER SHAFT
• 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 NJ 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: 21136358
• Report Number: 3008668801-2025-00004
• Device Sequence Number: 7676844
• Product Code: LXH
• UDI-Device Identifier: 03662200013210
• UDI-Public: 03662200013210
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 02/12/2026

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: RA90460129
• Device Lot Number: 120553004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/24/2025; 02/11/2026
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/24/2025; 02/12/2026
• 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 Sex: Unknown