MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 6.5 X 45MM MULTIAXIAL REDUCTION SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number 2000-7435

Device Problem Mechanical Jam (2983)

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

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Udi number: (b)(4).Without 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.

Event Description

It was reported that during surgery, the head of the screw was unable to rotate.The screw was removed and replaced with a new one.There were no reported patient impacts.

Manufacturer Narrative

Additional information in d10, h3, and h6: method, results, and conclusions codes.The returned screw was examined.The tulip head was found to bind up when attempting to rotate it.It is possible that damage to the screw head during insertion led to this binding seen.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that during surgery, the head of the screw was unable to rotate.The screw was removed and replaced with a new one.There were no reported patient impacts.

• Brand Name: 6.5 X 45MM MULTIAXIAL REDUCTION SCREW
• Type of Device: EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 8876847
• MDR Text Key: 153868645
• Report Number: 3012447612-2019-00329
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: K061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2000-7435
• Device Lot Number: J3592388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 105