PLAIN BAR 96 IN. (244 CM) TRAPEZE
Received Nov 24, 2020
Report 0001526350-2020-00984 · MDR key 10896730
Device
Generic name
Apparatus, Traction, Non-powered
Manufacturer
Zimmer Surgical, Inc.Model number
N/ACatalog number
00064000300
Lot number
N/A
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Clinical Signs, Symptoms or Conditions
- No Known Impact Or Consequence To Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Additional Manufacturer Narrative
THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE KNOB/SCREW HAD COME OFF OF SECTION 1 OF THE OVERHEAD BAR. PICTURES OF THE TRAPEZE, PART NUMBER 00064000300 AND SECTION 2 OF THE OVERHEAD BAR PART NUMBER 00096500100, WERE NOT PROVIDED. PN (B)(4). : LOT/SERIAL IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, AND LOT/SERIAL IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT CANNOT BE CONFIRMED.
Additional Manufacturer Narrative
THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT HELPER BROKE. THE EVENT TIMING WAS DURING PATIENT; HOWEVER, THERE WAS NO PATIENT HARM. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.