MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD POLARIS 5.5 TI MULTI-AXIAL SCREW INSERTER

Model Number N/A

Device Problem Break (1069)

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

Event Date 06/22/2015

Event Type  malfunction  

Event Description

While inserting a polaris translation screw, the tip of the inserter sheered off in the screw tulip.The screw was removed and screwdriver changed.And a second screw inserter tip sheered off at the same vb level.No adverse events were reported.

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.Report two of two for the same event, see also 3004485144-2015-00019.

Manufacturer Narrative

The polaris 5.5 ti multi-axial screw inserter, item # 14-500185, lot # pu63c was returned for evaluation.Visual examination of the returned device confirmed the reported damage; the tip has broken off in a manner consistent with torsional stress.A function check of the returned item cannot be performed due to the damaged condition of the driver.The length of the device was measured at 8.8740¿; the device drawing specifies the length as 8.975 ± 0.02¿, indicating approximately 0.101¿ of the driver tip has sheared off.The device history record (dhr) was reviewed; the drivers were received and inspected with no non-conformances noted.The hardness measured at the inspection was 53 hrc for the center shaft which is within the specification for the device (=48 hrc).The drivers were likely conforming when they left biomet control.The probable underlying root cause for the damage is excessive torque forces leading to loss of mechanical integrity and ultimately instrument deformation and fracture.It is possible that these excessive forces were the result of patient condition (hard bone, unique anatomy, etc.), improper technique, and/or misuse (excessive torque applied).(b)(4).

• Brand Name: POLARIS 5.5 TI MULTI-AXIAL SCREW INSERTER
• Type of Device: SCREW INSERTER
• 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: 4954276
• MDR Text Key: 21093695
• Report Number: 3004485144-2015-00020
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-500185
• Device Lot Number: PU63C
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1