6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MM
Received Apr 25, 2018 · Event occurred Apr 4, 2018
Report 9610612-2018-00204 · MDR key 7462962
Device
Generic name
Raniofix Resorbable Implants
Manufacturer
Aesculap Implant SystemsModel number
FF017Catalog number
FF017
Lot number
52375009
Product problems
- Device Operates Differently Than Expected
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING
Description of Event or Problem
(B)(6). SUTURE KNOT DID NOT WORK AND DISKS WAS NOT FIXED.
Additional Manufacturer Narrative
INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT: PANASONIC DMC TZ8. FIRST WE MADE A VISUAL INSPECTION OF THE INPLANT SYSTEM. EXCEPT THE SOILING WE NOTICED NO ABNORMALITIES. THE TREADS WERE ALL IN THE PRESCRIBED POSITION AND THE ROEDER KNOT IS INTACT. IN THE NEXT STEP WE TRIED TO PULL THE THREAD THROUGH THE KNOT. THIS WAS NOT POSSIBLE (AS THE COMPLAINT DESCRIBED). BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. THERE ARE NO FURTHER COMPLAINTS WITH THIS LOT AT HAND THE LAST THREE YEARS. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE IS MOST PROBABLY MANUFACTURING RELATED. RATIONAL: THE ROEDER KNOT SEEMS TIGHTENED TOO FIRMLY, SO IT DOES NOT WORK AS INTENDED. NO CAPA IS NECESSARY.