MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CERCLAGE CABLE WITH CRIMP 1.8 MM DIA.; PROSTHESIS, TRAUMA

Catalog Number 00223200118

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

It was reported that approximately three (3) weeks ago, the cable broke during surgery while surgeon was tightening it.All the cables used were pre-tightened and when the surgeon attempted to final tighten all the cables, one of them snapped.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Visual examination of the returned product identified the cable was broke.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot 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.

Event Description

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

• Brand Name: CERCLAGE CABLE WITH CRIMP 1.8 MM DIA.
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10757538
• MDR Text Key: 213875367
• Report Number: 0001822565-2020-03661
• Device Sequence Number: 1
• Product Code: KTT
• 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
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00223200118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1