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

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Unique identifier (udi) #: (b)(4).Concomitant medical product: biomet microfixation 90° contra angle driver catalog #: 24-1189 lot #: 172350.Therapy date: unknown.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 reports: 0001032347-2018-00867.

Event Description

It was reported a temporary fixation pin is stuck in the driver.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The 90 degree contra angle screwdriver (part# 24-1189, lot# 981670) was returned with a contra angle temporary fixation screw (part# 76-0017, lot# 636820) in the collet.The driver showed signs of moderate use with some minor discoloration on the handle and knob, likely from repeated autoclave cycles.The driver was functionally tested by attempting to remove the temporary fixation screw.The screw could not be removed.The driver was disassembled for further investigation.The screw was found to be not fully inserted into the collet upon removing the cover from the head assembly.The screw was difficult to push out.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event the blades being stuck in the driver was due to the connection issues due to the supplier using blades, and not the min/max gage, to design the collet resulting in the collet failing the max gage inspection.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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00867-1.

Event Description

This follow-up report is being submitted to relay additional information.

• 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: 8173771
• MDR Text Key: 131320108
• Report Number: 0001032347-2018-00868
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 76-0017
• Device Lot Number: 636820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1