MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. VITAL MIS SHORT CANNULATED TAP 4.5MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 850M5045

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2022-00202 through 3012447612-2022-00204.

Event Description

It was reported while inserting the 5.5mm x 45mm screw at t10 right side without tapping, the screw broke.Right after this, both 4.5mm taps broke when drilling a pilot hole on the right side of l2/l3 vertebral body.The broken screw remains implanted within the patient body.The taps were able to be removed using extra instruments.The patient has new leg pain when lying down and sitting post-operatively.The procedure was delayed two hours due to the breakage, removal, and re-inserting the screws.This is report two of three for this event.

Event Description

It was reported while inserting the 5.5mm x 45mm screw at t10 right side without tapping, the screw broke.Right after this, both 4.5mm taps broke when drilling a pilot hole on the right side of l2/l3 vertebral body.The broken screw remains implanted within the patient body.The taps were able to be removed using extra instruments.The patient has new leg pain when lying down and sitting post-operatively.The procedure was delayed two hours due to the breakage, removal, and re-inserting the screws.This is report two of three for this event.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported while inserting the 5.5mm x 45mm screw at t10 right side without tapping, the screw broke.Right after this, both 4.5mm taps broke when drilling a pilot hole on the right side of l2/l3 vertebral body.The broken screw remains implanted within the patient body.The taps were able to be removed using extra instruments.The patient has new leg pain when lying down and sitting post-operatively.The procedure was delayed two hours due to the breakage, removal, and re-inserting the screws.This is report two of three for this event.

Manufacturer Narrative

Device evaluation.Visual inspection revealed that the tip of the screw was fractured off, and the tips of both cannulated taps were fractured.Potential cause.Root cause was unable to be determined.This event could possibly be attributed to inserting the screw without tapping initially, or due to sclerotic bone.Dhr review.Per dhr review, the part was likely conforming when it left zimvie control.Device use.This device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: VITAL MIS SHORT CANNULATED TAP 4.5MM
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15314803
• MDR Text Key: 305492024
• Report Number: 3012447612-2022-00203
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887868458903
• UDI-Public: (01)00887868458903(10)4481201
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K203507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 850M5045
• Device Lot Number: 4481201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 100 KG