MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. CABLE 22 IN. (559 MM) LENGTH; CERCLAGE, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the cable fractured during tensioning.The surgery was completed with another device.No further information is available at the time of this reporting.

Event Description

No further information is available at the time of this reporting.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual inspection of the returned product noted the cable is fractured confirming the complaint.A dimensional analysis noted the product is conforming to specifications.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

• Brand Name: CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. CABLE 22 IN. (559 MM) LENGTH
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9334750
• MDR Text Key: 167765079
• Report Number: 0001822565-2019-04890
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• PMA/PMN Number: K151907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00223200118
• Device Lot Number: 64397532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other