MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SPINAL ROD CUTTER MAXIMUM PIN DIAMETER; TRAUMA, INSTRUMENT

Catalog Number 00392500200

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) report source - (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the instrument fractured during the procedure.There was no reported patient or user injury.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the provided pictures noted the fractured jaw of the instrument, confirming the complaint.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual inspection of the returned cutter noted the following - there was an unidentified lot number etched on the pin cutter.One jaw is fractured.Visual inspection of both jaws shows that they exhibit heavy wear marks.There was a design feature missing on the returned product of the part number provided.Accordingly, zimmer part no.Was ruled out as the possible identity of the subject instrument.As product identification is not possible no further evaluations could be performed.The complaint cannot be confirmed.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: SPINAL ROD CUTTER MAXIMUM PIN DIAMETER
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8863720
• MDR Text Key: 154905670
• Report Number: 0001822565-2019-03340
• 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,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00392500200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1