MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE

Model Number N/A

Device Problems Device Inoperable (1663); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: biomet microfixation 90 degree contra angle driver, catalog #: 24-1189, lot #: 807520.Therapy date: (b)(6) 2017.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00032.

Event Description

It was reported during a rib fixation for stabilization of rib fractures and flail segments case the contra angle screwdriver was needed to fixate ribs 2-4.The screwdriver handle was not turning smoothly; the handle would turn, but the screw would not rotate.The surgeon had to apply pressure to the back of the handle to ensure the screw was inserted smoothly.When attempting to remove the temporary fixation screw, it got stuck in the screwdriver and was unable to be removed.The driver could no longer be used although it was still needed.This created a delay of about fifteen to twenty minutes.A power driver and manual driver were used in its place; however, the surgeon could not fixate rib 2.There was no patient injury.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Product identity was not confirmed due to the product not being returned.The complaint is that a screw driver didn't turn smoothly and a fixation pin was stuck inside.Visual inspection and functional testing could not be performed due to the product not being returned.Therefore, the complaint cannot be verified and the most likely underlying cause cannot be determined.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.The driver was returned and the evaluation is in process; a follow-up mdr will be submitted on 0001032347-2018-00032.Not returned to manufacturer.

• Brand Name: RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE
• Type of Device: TEMPORARY FIXATION SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7190382
• MDR Text Key: 97859691
• Report Number: 0001032347-2018-00033
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 76-0017
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1