PREVISION LONGITUDINAL SLEEVE +10MM

Description of Event or Problem

UPDATE: THE REPORTED MEDICAL DEVICE OR A SIMILAR DEVICE IS NOT MARKETED IN THE U.S.

Description of Event or Problem

AN ADVERSE EVENT WAS REPORTED INVOLVING THE MEDICAL DEVICE NT1338P - PREVISION LONGITUDINAL SLEEVE +10MM. SPECIFICALLY, IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A FRACTURE OF THE MEDICAL DEVICE (PREVISION LONGITUDINAL SLEEVE) OCCURRED. APPROXIMATELY ONE MONTH AFTER BECOMING AWARE OF THE EVENT, THE MANUFACTURER WAS INFORMED THAT, DURING IMPLANTATION OF THE DISTAL IMPLANT, THE FRACTURE OF THE PREVISION LONGITUDINAL SLEEVE RESULTED IN THE PLASTIC SLEEVE REMAINING ON THE FIXED DISTAL STEM, NECESSITATING A BONE FENESTRATION. THIS ADDITIONAL INTERVENTION RESULTED IN A DELAY IN THE SURGICAL PROCEDURE. THE PLASTIC SLEEVE WAS SUCCESSFULLY RETRIEVED FOLLOWING THE BONE FENESTRATION, AND THE SURGICAL PROCEDURE WAS SUBSEQUENTLY COMPLETED. DURING THE COURSE OF FOLLOW-UP AND ONGOING INVESTIGATION OF THE REPORTED CASE, IT WAS REPORTED FROM THE HOSPITAL THAT THE PATIENT DIED ON (B)(6) 2026 AS A RESULT OF AN EMBOLIC EVENT. BASED ON THE INFORMATION AVAILABLE TO DATE, A DIRECT CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL DEVICE MALFUNCTION AND THE OCCURRENCE OF THE EMBOLISM CANNOT BE ESTABLISHED. IN ACCORDANCE WITH CURRENT KNOWLEDGE OF THE DEVICE'S INTENDED USE, DESIGN, AND MODE OF ACTION, THE DEVICE IS NOT CONSIDERED INHERENTLY CAPABLE OF CAUSING OR DIRECTLY CONTRIBUTING TO AN EMBOLIC EVENT. HOWEVER, IN LINE WITH THE PRINCIPLES OF ISO 14971 GUIDANCE ON CAUSALITY ASSESSMENT, AN INDIRECT CAUSAL RELATIONSHIP, FOR EXAMPLE VIA THE REPORTED PROCEDURAL DELAY, CANNOT BE EXCLUDED WITH THE CURRENTLY AVAILABLE INFORMATION. FURTHERMORE, PATIENT-SPECIFIC CHARACTERISTICS MUST BE TAKEN INTO ACCOUNT. THE PATIENT'S AGE (BORN IN 1945) REPRESENTS A RECOGNIZED INTRINSIC RISK FACTOR FOR THROMBOEMBOLIC EVENTS, AS REFLECTED IN CLINICAL LITERATURE AND STATE-OF-THE-ART KNOWLEDGE. THIS FACTOR IS THEREFORE CONSIDERED A RELEVANT CONTRIBUTING CONDITION INDEPENDENT OF DEVICE PERFORMANCE. THEREFORE, ON A PRECAUTIONARY BASIS AND PER THE MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, DEATH. THE ASSESSMENT REMAINS PRELIMINARY, AND CONCLUSIONS WILL BE UPDATED AS ADDITIONAL INFORMATION BECOMES AVAILABLE THROUGH CONTINUED INVESTIGATION. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS IS A SIMILAR DEVICE REPORT, A SIMILAR DEVICE OF THE REPORTED DEVICE WAS SOLD TO US; THE REPORTED DEVICE IS NOT MARKETED IN THE US.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION/ CORRECTION: B5 - DESCRIPTION UPDATED. WITH REFERENCE TO THE MANUFACTURER´S EMAIL RESPONSE DATED 2026-06-11 REGARDING THE INITIAL MEDWATCH REPORT, THE CASE WAS SUBMITTED AS A SIMILAR DEVICE REPORT AS A PRECAUTIONARY MEASURE FOLLOWING THE REPORTED PATIENT HARM. HOWEVER, SUBSEQUENT INVESTIGATION AND VERIFICATION CONFIRMED THAT NEITHER THE REPORTED DEVICE NOR A SIMILAR DEVICE IS MARKETED IN THE UNITED STATES. THEREFORE, ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3 AND 803.50, THIS EVENT IS CONSIDERED NO LONGER REPORTABLE FOR THE FOLLOWING REASON: THE MEDICAL DEVICE OR A SIMILAR DEVICE IS NOT MARKETED IN THE U.S.