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

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product: biomet microfixation 90° contra angle driver, catalog #: 24-1189, lot #: 191750.Therapy date: (b)(6) 2018.Product has been received by zimmer biomet and the investigation is in process.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: 0001032347-2018-00321.

Event Description

It was reported a pin became locked in the driver.The issue was identified after the case when the hospital staff was breaking down the equipment.No adverse events have been reported as a result of the malfunction.

Event Description

This report is being submitted to document the results of the device evaluation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The 90 degree contra angle screwdriver (part# 24-1189, lot# 191750) and contra angle temporary fixation screw (part# 76-0017, lot# unknown) were returned in a biohazardous condition.Visual inspection of the device through the bag shows there is a temporary fixation screw still stuck in the driver's collet.The device was removed from the biohazard bag and discoloration was observed.Functional testing confirms that the pin can not be removed.Device history record (dhr) of the screwdriver was reviewed and no discrepancies were found.Device history record (dhr) review was unable to be performed for the temporary fixation screw as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to the manufacturer's inspection methods.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: 0001032347-2018-00321-1.

• 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: 7557898
• MDR Text Key: 110048593
• Report Number: 0001032347-2018-00322
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• 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: (01)00841036202255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1