MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION EPMP6 PEG EXTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	RA90310180
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4): serf (b)(6); during the surgery, during the revision of total hip prothesis: the device was broken during the plot extraction.
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 (b)(4): serf (b)(4) during the surgery, during the revision of total hip prothesis: the device was broken during the plot extraction.
Additional Manufacturer Narrative
Correction of product code in section d2b.Correction of common device name d2a.Investigation conclusion: an event regarding crack/facture involving a bi mentum peg extractor - epmp6 was reported.The reported device is an serf product.Device has not been returned.No technical investigation can be realized.Documentary investigation: - pfra90310180b of number 122680015.- no nc has been observed for the manufacturing of the batch.The end of manufacturing for this batch is 05 march 2020 according to our erp system.Ifu §7 "reprocessing limits of instruments": - the life expectancy is estimated at 81 uses, equivalent to a 3-year useful life.- if a defect of function or identification is detected by a customer, the instrument shall not be used.The most probable cause is the device reaching the end of its useful life.

• Brand Name: EPMP6 PEG EXTRACTOR
• 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, FL 69150 ; FR 69150 ; 9546280700
• MDR Report Key: 21230321
• Report Number: 3008668801-2025-00067
• Device Sequence Number: 12872423
• Product Code: LXH
• UDI-Device Identifier: 03662200012954
• UDI-Public: 03662200012954
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/04/2026

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: RA90310180
• Device Lot Number: 122680015
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/04/2026
• 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