MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE CUTTER 1.8 MM MAXIMUM CABLE DIAMETER; TRAUMA, INSTRUMENT

Catalog Number 00392501100

Device Problem Failure to Cut (2587)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - foreign - (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.Product not returned.

Event Description

It was discovered that the cable cutter does not cut the cable.The instrument causes the cable to fray and be crushed.There was no patient involvement.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.In the video provided, it is noticed that the wire is unraveling as they are cutting.That wire in the video has many crimp marks so the wire used was in poor condition contributing to the unraveling that was occurring.It has been determined that to perform the cut test correctly, the cable must be new and the cutting motion has to be swift.The intended clinical application is to have the cable under tension.Review of the device history record (dhr) found 25 jaws were scrapped as the jaws do not cut the cable, which could likely be related to the reported event.A summary of the investigation has been sent to the complainant.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.

Event Description

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

• Brand Name: CABLE CUTTER 1.8 MM MAXIMUM CABLE DIAMETER
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8632633
• MDR Text Key: 145802213
• Report Number: 0001822565-2019-02135
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00392501100
• Device Lot Number: 64302473
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1