MAUDE Adverse Event Report: KERI MEDICAL SA KERIFLEX PROGRESSIVE PROXIMAL RASP PIP

Model Number	211-A43000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon further review of this event, we have determined that this event meets the fda's definition of a serious injury, as it required unplanned surgical intervention to prevent potential permanent impairment or damage.In accordance with 21 cfr part 803, we are therefore reporting this event to the fda.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 (evaluation of the returned instrument, review of the device history record, and an assessment of relevant complaint history), it was determined that the most likely root cause of the breakage was the application of force along an abnormal or unintended axis during use.This off-axis loading could have exceeded the mechanical limits of the instrument, leading to its fracture.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 during the procedure, the rasp broke off and the broken part was stuck in the bone and this was difficult to remove.The time of the surgery has been extended by 45 minutes.This event involved unplanned surgical intervention to remove the fragment.

• Brand Name: KERIFLEX PROGRESSIVE PROXIMAL RASP PIP
• Common Device Name: KERIFLEX PROGRESSIVE PROXIMAL RASP PIP
• 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: 24470902
• Report Number: 3024706-2026-00007
• Device Sequence Number: 15848264
• Product Code: GAC
• UDI-Device Identifier: 07640181161560
• UDI-Public: 07640181161560
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 211-A43000
• Device Catalogue Number: 211-A43000
• Device Lot Number: G30000421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown