PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE
Received Aug 24, 2016 · Event occurred Aug 9, 2016
Report 2520274-2016-14333 · MDR key 5899882
Device
Product problems
- Break
- Break
Patient
69 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE TO REPAIR A FRACTURED DISTAL CLAVICLE ACROMIOCLAVICULAR (AC) JOINT ON (B)(6) 2016, WHILE INSERTING A 3.5MM LOCKING COMPRESSION PLATE (LCP) PLATE, THE HANDLE OF A 6MM PERIOSTEAL ELEVATOR BROKE APART IN THE SURGEON'S HAND, CUTTING THE SURGEON'S GLOVE. THE HANDLE OF THE DEVICE BROKE INTO TWO PIECES; APPROXIMATELY 25 PERCENT OF THE HANDLE WAS STILL ATTACHED TO THE DEVICE AND APPROXIMATELY 75 PERCENT BROKE OFF. THERE WAS A ONE (1) MINUTE DELAY WHILE THE SURGEON RE-GLOVED AND OBTAINED ANOTHER DEVICE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE INSTRUMENT WITH NO HARM TO THE PATIENT OR THE SURGEON. THIS REPORT IS 1 OF 1 FOR (B)(4).