CONCEPT LINEAR WIDE BITE PUNCH, STRAIGHT
Received Jun 13, 2019
Report 1017294-2019-00069 · MDR key 8695407
Device
Generic name
Orthopedic Manual Surgical Instrument
Manufacturer
Tecomet, Inc.Catalog number
C6855
Lot number
0318A
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
TO DATE, THE REPORTED DEVICE HAS NOT BEEN RETURNED TO CONMED FOR EVALUATION. SHOULD THE DEVICE BE RETURNED AN EVALUATION WILL BE PERFORMED. UPON COMPLETION OF THE COMPLAINT INVESTIGATION A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED. OTHERWISE THIS FILING WILL STAND AS THE FINAL REPORT. THE MANUFACTURING DOCUMENTS FOR THIS DEVICE HISTORY REPORT COULD NOT BE REVIEWED SINCE THE DEVICE IS NOT MANUFACTURED BY CONMED. A TWO-YEAR LOT HISTORY REVIEW SHOWS A TOTAL OF TWO (2) COMPLAINTS FOR THIS LOT NUMBER AND FAILURE MODE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: INTENDED USE: THESE INSTRUMENTS ARE INTENDED FOR USE ON SOFT TISSUE ONLY. CAUTIONS: INSPECT INSTRUMENTS PRIOR TO USE TO ENSURE PROPER FUNCTION; NO LOOSE PINS OR MISALIGNMENT, AND THAT THE INSTRUMENT IS IN GOOD PHYSICAL CONDITION. INSPECT INSTRUMENTS AFTER USE TO ENSURE IT HAS NOT BEEN DAMAGED. DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE. AVOID UNINTENDED CONTACT WITH OTHER SURGICAL INSTRUMENTS DURING USE TO PREVENT DAMAGE OR BREAKAGE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
Additional Manufacturer Narrative
THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
Description of Event or Problem
THE CUSTOMER REPORTED THAT C6855 DEVICE WELD BROKE DURING SURGERY. THE PROCEDURE AND DATE OF PROCEDURE IS NOT KNOWN. THERE WAS NO REPORT OF INJURY TO STAFF OR PATIENT. THERE IS NO MENTION THAT A PATIENT WAS INVOLVED. A GOOD FAITH EFFORT HAS BEEN EXECUTED TO GAIN MORE INFORMATION REGARDING THE EVENT; HOWEVER, THERE HAS BEEN NO RESPONSE FOR FURTHER INFORMATION TO DATE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.