MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD POLARIS SPINAL SYSTEM -TRANSLATION SCREW; POLARIS TRANSLATING 5.5 TI 7.5X40MM SCREW

Model Number N/A

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2015

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.Report one of two for the same event, see also 3004485144-2015-00065.

Event Description

The sales associate reported a broken screw and 2 broken screwdrivers that broke in the screw.The surgeon was removing competitive screws from the patient during this t11-s1 procedure.At s1, he removed a 7.5 x 40mm screw and installed polaris translation of the same size into the same screw hole.During final tightening, the surgeon heard a loud crack and thought the screw housing had splayed open.He tried to remove it and replace it with a different screw.During this removal, he found that the driver tip had broken; this was the crack he heard.He helicoptered the screw to remove it, but the screw shaft broke in the neck section, so the housing and its subcomponents became detached from the threaded portion of the screw.He then used a competitive instrument to remove the screw.While installing a second translation screw into the same hole, the surgeon broke a second driver but was able to position that screw into place.There was a delay of 30-40 minutes while the first screw was removed, but there was no harm to the patient.

• Brand Name: POLARIS SPINAL SYSTEM -TRANSLATION SCREW
• Type of Device: POLARIS TRANSLATING 5.5 TI 7.5X40MM SCREW
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 5150326
• MDR Text Key: 28307491
• Report Number: 3004485144-2015-00064
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Report Date: 09/14/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-578540
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention