OTTOBOCK 1C61 TRITON VS

Description of Event or Problem

A COMPLAINT (B)(4) WAS RECORDED IN OTTO BOCK'S SAP SYSTEM ON (B)(6) 2025, WITH THE MANUFACTURER HAVING REPORTABLE AWARENESS AS OF (B)(6) 2025. EVENT INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER, BUT THE DEVICE IS STILL PENDING RETURN TO THE MANUFACTURER FOR EVALUATION AND ROOT CAUSE INVESTIGATION. THE END-USER ALLEGEDLY FELL DUE TO A FAILURE OF THE FUNCTIONAL RING (A COMPONENT OF THEIR 1C61 FOOT) AND BROKE THEIR TWO FRONT TEETH. THE TWO FRONT TEETH REQUIRED REPAIR BY A DENTIST. FURTHER INFORMATION ABOUT THE EVENT AND MEDICAL DEVICE WILL BE REPORTED IN A FINAL REPORT BY 2/27/2026.

Additional Manufacturer Narrative

THE FOOT WAS RETURNED TO OTTOBOCK FOR INVESTIGATION. OVERALL, THE CONDITION OF THE FOOT WAS GOOD. SPRINGS, FASTENERS, AND URETHANE BONDS WERE ALL WITHIN SPECIFICATION. THE FUNCTIONAL RING IN THE VERTICAL SHOCK FOOT COMPONENT WAS CATASTROPHICALLY DAMAGED DURING THE FALL REPORTED. DISASSEMBLY OF THE VERTICAL SHOCK FOOT COMPONENT ALSO REVEALED WORN O-RINGS ON THE SHAFT. ALTHOUGH THE FOOT WAS IN GOOD CONDITION AND FIT WITHIN INDICATIONS, THE CATASTROPHIC DAMAGE TO THE FUNCTIONAL RING WAS CAUSED BY "EXCESSIVE STRAIN" DUE TO THE FALL REPORTED. GIVEN ADDITIONAL EVIDENCE REGARDING THE WORN O-RINGS ON THE SHAFT IT IS MOST LIKELY THE FUNCTIONAL RING HAD EXISTING DAMAGE (I.E. PARTIAL CRACK) THAT WAS NOT RECOGNIZED DURING ROUTINE CHECKS BY THE END-USER BEFORE EACH USE. IN ADDITION THE 1C61 WAS DELIVERED TO THE END-USER (B)(6) 2025 WITH NO INDICATION THE FUNCTIONAL RING WAS EVER SERVICED ON A 6-MONTH INTERVAL AS REQUIRED. HAD THE PROPER FUNCTIONAL RING FIELD SERVICE MAINTENANCE BEEN ADHERED TO AT 6-MONTHS USE-TIME THE CATASTROPHIC DAMAGE TO THE FUNCTIONAL RING LIKELY WOULD NOT HAVE OCCURRED. AS THIS WAS CLEAR MISUSE OF THE DEVICE, NO FORMAL CORRECTIVE ACTIONS WERE TAKEN BY THE MANUFACTURER. IN ADDITION, NO EXCURSIONS OF COMPLAINT RATE OR FAILURE MODE RATE HAVE BEEN OBSERVED FOR THE 1C61 THAT WOULD TRIGGER ESCALATION TO CAPA OR FSCA. RISK EVALUATION ALSO CONFIRMED NO CHANGE TO THE RISK-BENEFIT RATIO AS A RESULT OF THIS EVENT. REGARDLESS OF THE CONFIRMED MISUSE, THE 1C61 WAS REPLACED BY THE USER-PROFESSIONAL WITH A NEW 1C61. NO FURTHER COMPLAINTS FROM THE SAME END-USER HAVE BEEN RECORDED AGAINST THE NEW 1C61 THAT WAS FIT IN RESPONSE TO THIS ADVERSE EVENT. DUE TO THE ADVERSE EVENT THAT RESULTED FROM THE FALL CAUSED BY THE END-USER DAMAGE AND MISUSE, MANDATORY REPORTS (FDA MDR AND EU MIR) WILL BE SUBMITTED TO THE FDA (US) AND ANSM (FRANCE).

Description of Event or Problem

A COMPLAINT (B)(4) WAS RECORDED IN OTTO BOCK'S SAP SYSTEM ON DEC. 1, 2025, WITH THE MANUFACTURER HAVING REPORTABLE AWARENESS AS OF DEC. 2, 2025. THE END-USER ALLEGEDLY FELL (ON (B)(6) 2025) DUE TO AN ALLEGED FAILURE OF THE FUNCTIONAL RING (A COMPONENT OF THEIR 1C61 FOOT) AND BROKE THEIR TWO FRONT TEETH. THE TWO FRONT TEETH REQUIRED REPAIR BY A DENTIST.