ACCULAN 3TI DRILL AND REAMER
Received Jun 20, 2019
Report 9610612-2019-00404 · MDR key 8717942
Device
Generic name
Large Bone Power Systems
Manufacturer
Aesculap AgModel number
GA672Catalog number
GA672
Lot number
52469549
Product problems
- Mechanical Problem
- Unintended Movement
- Mechanical Problem
- Unintended Movement
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. INVESTIGATION: THE INVESTIGATION HAS BEEN CARRIED OUT BY THE AESCULAP TECHNICAL SERVICE (ATS). THE COMPLAINED DEVICE HAS BEEN DELIVERED IN DECEMBER 2018. DURING A FUNCTION TEST, NOT FAILURE REGARDING THE SPEED PUSHER OF THE DEVICE COULD BE DETECTED, THEREFORE THE MENTIONED FAILURE COULD NOT BE RECONSTRUCTED. HOWEVER, A CHAFING OF THE MENTIONED PUSHER IS NOTICEABLE. NEVERTHELESS, THE PUSHER ALWAYS MOVES BACK IN ITS INITIAL POSITION AND THE DEVICE WORKS AS INTENDED. AFTER THE DISASSEMBLY OF THE PUSHER, CLEAR CHAFE MARKS AND A NOTCH CAN BE FOUND. DUE TO THE PARTIAL DAMAGE IT IS POSSIBLE THAT A BURR LOOSENED UP AND LED TO THE BLOCKAGE OF THE PUSHER UNIT. WE ASSUME THAT A FALL OR AN IMPACT DAMAGE LED TO THE ABOVE MENTIONED ISSUE. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS FOR THE ABOVE MENTIONED LOT NUMBER HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER. CONCLUSION AND ROOT CAUSE: THE FAILURE IS MOST PROBABLY USAGE RELATED. NO CAPA NECESSARY.
Description of Event or Problem
THE REPORTER INDICATED THAT WHILE USING THE DRILL THE SURGEON RELEASED THE TRIGGER AND THE DRILL/REAMER CONTINUED TO WORK. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED.