MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION GE007-51 TRIAL CUP 51; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	RA90390951
Medical Device Problem Codes	Fracture (1260); Sharp Edges (4013)
Health Effect - Clinical Codes	Discomfort (2330); Needle Stick/Puncture (2462)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Serf rc-23-0198 following a report of an aes by the technician during a thp operation (injury with a metal splinter from the trial cup), the operating theatre requested a deposit exchange for all the trial cups and the cup holder in the box.The references are given below: ge007-45 / ge007-47 / ge007-49 / ge007-51 / ge007-53 / / ge007-55 / ge007-57 / ge007-59 / ge007-61 / ext007.
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.
Additional Manufacturer Narrative
Correction product code section d2b.Correction common device name section d2a.Correction g4: 510k exempt.Conclusion of investigation: an event regarding thread damage involving a ge007-51 trial cup 51 was reported.The reported device is an serf product.Documentary investigation: the review of 125912005 did not reveal any anomalies.73 units were manufactured by subcontractor cefimeca in 2021.The inspection report and certificate of conformity were checked and found to be compliant by the release department on january 26, 2022.Technical investigation: the ge007-51 test gauge was returned on 01/17/2024.The subject of the complaint is a ¿metal splinter.¿ after visual inspection, it was found that the thread is damaged and that a metal splinter is present inside the gauge.The ext007 handle screws into the thread of the ge007-51.The operator must have exerted unusual force because the thread of the gauge was damaged and the screw axis was not respected, which certainly caused a splinter.Finally, the template is held in place by the rounded side (outer side) to avoid interference when screwing in the ext007 handle.In conclusion, as the template's thread is damaged, the identified cause would be improper handling of the template with another instrument that would have exerted unusual force.

• Brand Name: GE007-51 TRIAL CUP 51
• 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: 21230585
• Report Number: 3008668801-2025-00069
• Device Sequence Number: 7559642
• Product Code: LXH
• UDI-Device Identifier: 03662200012657
• UDI-Public: 03662200012657
• 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: RA90390951
• Device Lot Number: 125912005
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 01/29/2026
• 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