MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE-READY CABLE GRIP SYSTEM CABLE CUTTER; EXTREMITY, INSTRUMENT

Model Number N/A

Device Problems Dull, Blunt (2407); Failure to Cut (2587)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that, the cable cutter did not cut the cable during a test in the warehouse before distribution.There was no patient involvement.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.The product was evaluated and noted the product is operating without any issues.Device history record (dhr) review was not performed as the product is conforming and operating within specifications.The device analysis indicated that the device met specification.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: CABLE-READY CABLE GRIP SYSTEM CABLE CUTTER
• Type of Device: EXTREMITY, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8609914
• MDR Text Key: 145095346
• Report Number: 0001822565-2019-02025
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• 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: 00392501100
• Device Lot Number: 64218646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1