MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 7.5X50MM TRANSLATION SCREW; POLARIS SPINAL SYSTEM -TRANSLATION SCREW

Catalog Number 14-578550

Device Problem Difficult to Remove (1528)

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

Event Date 06/23/2018

Event Type  Injury  

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.Reference report 3012447612-2018-00608.

Event Description

It was reported that the tip of a driver broke off while installing a screw during surgery.The screw's tulip was cut off so the screw's shaft could be removed and replaced with an alternative screw.An alternative screw driver was also used to complete the procedure.There was a delay greater than 30 minutes in length, but there were no reported patient impacts associated with the delay.This is report two of two for this event.

Manufacturer Narrative

The returned device was examined.The device was received in a manner that prevented an investigation; therefore, no findings are available and a cause cannot be established.There were no manufacturing issues detected which would have contributed to this event.

Event Description

It was reported that the tip of a driver broke off while installing a screw during surgery.The screw's tulip was cut off so the screw's shaft could be removed and replaced with an alternative screw.An alternative screw driver was also used to complete the procedure.There was a delay greater than 30 minutes in length, but there were no reported patient impacts associated with the delay.This is report two of two for this event.

• Brand Name: 5.5 TI 7.5X50MM TRANSLATION SCREW
• Type of Device: POLARIS SPINAL SYSTEM -TRANSLATION SCREW
• 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: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7763593
• MDR Text Key: 116445017
• Report Number: 3012447612-2018-00609
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK140123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-578550
• Device Lot Number: 2414641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 136