MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 7.5X55MM TRANSLATION SCREW; POLARIS SPINAL SYSTEM -TRANSLATION SCREW

Catalog Number 14-578555

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 3012447612-2019-00556 to 3012447612-2019-00558 and 3012447612-2019-00566.

Event Description

It was reported that during the procedure, while attempting to screw into extremely hard bone, the screw stopped advancing.The surgeon attempted to put the driver in reverse and back out the screw but the tip of the driver sheared off.The surgeon tried a second driver whose tip also sheared off and a dorsal height adjuster that broke.The surgeon was unable to advance or remove the screw, so he cut off the top of screw and left half of the screw shaft embedded within the bone.A screw was unable to be placed on this side at this level of the construct.There were no reported impacts associated with the screw shaft.This is report four of four for this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11: catalog#: 14-500185 pol 5.5 ti maxl scr insrt univ lot#: pz19c.Catalog#: 14-500070 pol trans btn lk scr insrtr lot#: pz17a.Catalog#: 2000-9072 pol 5.5 ti dorsal height adjer lot#: pp70b.Catalog#: 14-500185 pol 5.5 ti maxl scr insrt univ lot#: pz19c.Catalog#: 14-500070 pol trans btn lk scr insrtr lot#: px74b.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was unable to be determined.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: 5.5 TI 7.5X55MM TRANSLATION SCREW
• Type of Device: POLARIS SPINAL SYSTEM -TRANSLATION SCREW
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9506992
• MDR Text Key: 172393708
• Report Number: 3012447612-2019-00566
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K140123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-578555
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other