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

Model Number N/A

Device Problem Dull, Blunt (2407)

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

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(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 reported that the cutter did not cut cable.The cable frayed.No patient involvement, event reported during inspection at the distributor.No further event information is available at the time of this report.

Manufacturer Narrative

Udi# (b)(4).Visual examination of the returned product identified that the jaws did not close all the way.Functional check was made and the cutter did not cut the wire completely.The device history records were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified: 12 pieces are scrapped due to jaws not cutting the cable.Root cause was unable to be determined.Further actions have been indicated through capa process to investigation this issue.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 is available at the time of this report.

• Brand Name: CABLE CUTTER 1.8 MM MAXIMUM CABLE DIAMETER
• Type of Device: TRAUMA INSTRUMENTATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8636024
• MDR Text Key: 145931262
• Report Number: 0001822565-2019-02185
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• 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: 64371308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1