MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PLAIN BAR 96 IN. (244 CM) TRAPEZE; APPARATUS, TRACTION, NON-POWERED

Model Number N/A

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.

Event Description

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.

Event Description

No additional event information available.

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.

• Brand Name: PLAIN BAR 96 IN. (244 CM) TRAPEZE
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10896730
• MDR Text Key: 218236680
• Report Number: 0001526350-2020-00984
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00064000300
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1