MAUDE Adverse Event Report: KERI MEDICAL SA KERIFLEX PIP 1; KERIFLEX® - PIP FINGER JOINT IMPLANT - PIP 1

Model Number	KERIFLEX® - PIP FINGER JOINT IMPLANT - PIP 1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed since the affected device was returned for investigation.A review of the device history record for the reported lot did not indicate any abnormalities related to the reported event.After a thorough investigation (returned device, device history record review, medical imaging, complaint history review), it appears that the most likely root cause of the failure could be associated with patient related factors (recurrence of breakages) and/or an improper realignment of the finger, resulting in abnormal stress on the implant.The identified root cause represents the most likely explanation based on current evidence and does not constitute definitive proof of causality.
Event or Problem Description
It was reported that the patient (a 72-year-old female) underwent a second revision surgery following a radial collateral ligaments rupture.The revision occurred on (b)(6) 2025, leading to arthrodesis.Implant was found broken.

• Brand Name: KERIFLEX PIP 1
• Common Device Name: KERIFLEX® - PIP FINGER JOINT IMPLANT - PIP 1
• Manufacturer (Section D): KERI MEDICAL SA; chemin du pre-fleuri 5; plan-les-ouates, 1228 ; SZ 1228
• Manufacturer (Section G): KERI MEDICAL FRANCE; 34 rue antoine redier; archamps, 74160 ; FR 74160
• Manufacturer Contact: camille miletto ; chemin du pre-fleuri 5; plan-les-ouates, 1228 ; SZ 1228
• MDR Report Key: 23705394
• Report Number: 3024706750-2025-00026
• Device Sequence Number: 10649499
• Product Code: KYJ
• UDI-Device Identifier: 07640181160655
• UDI-Public: 07640181160655
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K211385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: KERIFLEX® - PIP FINGER JOINT IMPLANT - PIP 1
• Device Catalogue Number: 210-P20001
• Device Lot Number: 059822008000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female