MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SPINAL ROD CUTTER MAXIMUM PIN DIAMETER 6.4 MM (1/4 IN.); CUTTER, WIRE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

It was reported that during a spinal fusion procedure, while the medical professional was using a bolt cutter to trim down the cobalt rod, the bolt cutter fractured off into the patient.The fragment was removed from the patient.X-rays did not show any retained fragments.No additional patient consequences were noted.

Event Description

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

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.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.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.

• Brand Name: SPINAL ROD CUTTER MAXIMUM PIN DIAMETER 6.4 MM (1/4 IN.)
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7844027
• MDR Text Key: 119115655
• Report Number: 0001822565-2018-04792
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00392500200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention