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 Problems Spinal Cord Injury (2432); Blood Loss (2597); No Code Available (3191)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 surgeon was cutting a spinal rod during the procedure when the cutting jaw broke off of the spinal rod cutter.The device fractured during use with no fractured pieces falling into the patient; however, this did cause a delay to the case of an hour.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the surgeon was cutting a spinal rod during the procedure when the cutting jaw broke off of the spinal rod cutter.The device fractured during use with no fractured pieces falling into the patient; however, this did cause a delay to the case of an hour.Bleeding was noted on the patient's spinal cord.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon was cutting a spinal rod during a spinal fusion procedure, when the cutting jaw broke off of the spinal rod cutter.The device fractured during use with no fractured pieces falling into the patient; however, this did cause a delay to the case of an hour.Bleeding was noted on the patient's spinal cord.The surgeon documented intraoperative spinal cord trauma and it was reported that the patient has remained paraplegic post-operatively.Outcome was determined to be uncertain.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Concomitant medical products: unknown stryker xia-3 system spinal implant, cat#: 48238400 lot#: ni.Unknown stryker xia-3 system spinal implant, cat#: 48238400s lot#: ni.Complaint sample was evaluated and the reported event was confirmed.Failure mode was that of instrument fracture.Inspection of the device identified that one of the jaws was fractured.There was no product identification etch present on the product.There was design feature missing on the returned part and the dimensions do not conform to the print specifications of the part number provided (00-3925-002-00).As product identification is not possible no further evaluations could be performed.Part and lot identification are necessary for review of device history records, neither were provided.From the legal documents provided, it was noted that a zimmer biomet spinal rod cutter was used to cut a competitor implant made of titanium.In the instrument/ provisional use, care, and sterilization document, it was mentioned to "use only instruments and provisionals specifically designed for use with their associated devices and misuse reduces useful life and/ or increase injury risk.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation 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

Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

Upon receipt of additional information, it has been determined that the returned device in the alleged event was not zimmer biomet product.The initial report was forwarded in error and should be voided.

• 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: 7298717
• MDR Text Key: 101001368
• Report Number: 0001822565-2018-00773
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/10/2019

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00392500200
• Device Lot Number: 61179726
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 03/05/2018; 04/27/2018; 06/14/2018; 07/17/2018; 04/03/2019
• Supplement Dates FDA Received: 03/28/2018; 05/23/2018; 06/20/2018; 08/14/2018; 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 70 YR
• Patient Weight: 82