inforMED
InjuryEGN

KELLY SCISSORS,STRAIGHT,16CM,6

Received Aug 31, 2017

Report 0001032347-2017-00701 · MDR key 6834781

Device

Generic name

Scissors, Surgical Tissue, Dental

Model number

N/A

Catalog number

51-0985

Lot number

SEE H10 NARRATIVE

Product problems

  • Fracture
  • Fracture

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE SCISSORS (PART #51-0985, LOT #UNKNOWN) SHOWED SIGNS OF MODERATE WEAR. UPON INSPECTION THE INSTRUMENT WAS FOUND TO BE IN DECENT OVERALL CONDITION WITH SOME DISCOLORATION AND SCRATCHING DUE TO NORMAL WEAR. BOTH OF THE TIPS WERE FRACTURED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED DUE TO THE AGE OF THE POSSIBLE LOTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE INSTRUMENT EXPERIENCED EXCESSIVE FORCE BEYOND WHAT IT WAS DESIGNED TO ENCOUNTER. THE INSTRUCTIONS FOR USE (IFU) FOR GENERAL INSTRUMENTATION HAS THE FOLLOWING INFORMATION PROVIDED IN THE SECTION TITLED WARNINGS AND PRECAUTIONS: AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. LOT NUMBER AND DEVICE MANUFACTURE DATE: THERE IS NO VISIBLE LOT ETCH ON THE PRODUCT. POTENTIAL LOTS THAT WERE SOLD TO THIS CUSTOMER ARE LOT 425065 MANUFACTURED 12/16/1996, LOT 511093 MANUFACTURED 2/16/1998, & LOT 535127 MANUFACTURED 2/16/1998.

Additional Manufacturer Narrative

WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

Description of Event or Problem

IT WAS REPORTED THE TIP FRACTURED. THERE WAS NO INJURY AND NO DELAY. THE FRACTURED PIECES WERE REMOVED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED AT THIS TIME.