MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD SELF RETAINING INSERTER SHORT

Model Number N/A

Device Problems Detachment Of Device Component (1104); Fracture (1260); Fitting Problem (2183); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/14/2015

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.Report one of three for the same event, see also 3004485144-2015-00097 and 00098.

Event Description

The sales associate reported the surgeon was using polaris 5.5 on (b)(6) 2015 in a lumbar case.He was using the specialty driver for the standard screws (2000-2445 x2 and 2000-2450 x2).The first two screws were implanted into the pedicle fine.While implanting the next screw he disengaged the driver from the screw and when he inserted the driver back in the same screw to tighten more, the driver was not fully seated into the screw properly, and the screw was inserted through the pedicle laterally, fracturing the vertebral body.The surgeon explanted all the screws and completed the surgery using a different system.

Manufacturer Narrative

The returned lv01143 (self retaining inserter short) from lot 307466 was visually inspected by quality engineering.The dhr for the product lot was reviewed; there were no non-conformances or deviations reported that could have contributed to the reported device failure.Initial inspection does not suggest the product is non-conforming or damaged.The inserter properly mates and retains itself with applicable handles and the pentalobe tip does not show signs of excessive wear or fracture.A functional analysis was performed; inspection and analysis did not yield any observable failure mode with the device.The device was tested by mating the inserter with a polaris mas screw (p/n 2000-2430) and performing its insertion function.The driver worked as intended; however, not to the surgeon's expectations for being a specialty device.The reported complaint is unconfirmed.Actual device failure was not confirmed by visual or functional assessment.The root cause of the reported event is likely attributed to operator preference.

• Brand Name: SELF RETAINING INSERTER SHORT
• Type of Device: 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: 5245969
• MDR Text Key: 32004851
• Report Number: 3004485144-2015-00096
• Device Sequence Number: 1
• Product Code: HXX
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• 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: LV01143
• Device Lot Number: 307466
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• 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
• Patient Outcome(s): Other