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

Model Number N/A

Device Problems Defective Device (2588); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Medical product - biomet microfixation contra angle driver catalog #: 24-1189, lot #: 172310.Complaint sample was evaluated and the reported event was confirmed.The driver was returned with a contra angle temporary fixation screw stuck inside the collet.The screw was also fractured.Functional testing was done by attempting to remove the screw.The screw could not be removed, therefore the complaint is confirmed.The driver was disassembled for further inspection.When the cover of the head assembly was removed, it was noted that the temp fix screw had rotated inside the driver, which prevented it from being removed.The temp fix screw was rotated and removed from the collet.There was some debris that fell out upon removal of the screw.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force being applied, beyond what is required to seat the screw.The excessive torque wore down the amount of interference between the solid shaft of the screw and the driver's collet, then caused the collet to rotate around the screw.The d-shaped hole in the driver's head assembly rotated around the screw and the locking end of the screw became stuck on the edge.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00355 & 0001032347-2019-00217-1.

Event Description

It was reported by the sales associate that a temporary fixation screw became stuck in one driver and another driver was hard to turn.No adverse events have been reported as a result of the malfunction.

• Brand Name: RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE
• Type of Device: BLADE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: alan munoz ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 8770063
• MDR Text Key: 192637158
• Report Number: 0001032347-2019-00356
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036202255
• UDI-Public: 00841036202255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• 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: 76-0017
• Device Lot Number: 703610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2016
• 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