MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD POLARIS 5.5 TI PLUG DRIVER

Model Number N/A

Device Problems Break (1069); Detachment Of Device Component (1104); Naturally Worn (2988)

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

Event Type  malfunction  

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.

Event Description

The sales associate reported the tip of the instrument was worn and broke off during torquing.There were no adverse events reported.

Manufacturer Narrative

The polaris 5.5 plug driver, item # 2000-9061, lot # pp97t was returned evaluation.Visual inspection of the item shows the tip of the driver has sheared off consistent with excessive torque applied to the driver.A function check of the returned item cannot be performed because the device is too damaged to engage a plug.The device history records were reviewed and no non-conformances were noted.The hardness measured at the inspection (55 rc) was within the specification for the device (rc 48 min.).The possible adverse effects 2.Loss of fixation or bending, fracture, loosening or migration of the implant or instruments are listed in the package insert.The root cause of this event cannot be conclusively determined with the available information.The probable underlying root cause for the damage is excessive torque forces leading to loss of mechanical integrity and ultimately instrument deformation and fracture.Report one of two for the same event, see also 3004485144-2015-00110.

• Brand Name: POLARIS 5.5 TI PLUG DRIVER
• Type of Device: PLUG DRIVER
• 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: 5039004
• MDR Text Key: 25155021
• Report Number: 3004485144-2015-00045
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK141804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/31/2015

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 Model Number: N/A
• Device Catalogue Number: 2000-9061
• Device Lot Number: PP97T
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1