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

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: biomet microfixation ribfix blu system 90° contra angle driver catalog #: 24-1189, lot #: 490190.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: 0001032347-2018-00426.

Event Description

It was reported a temporary fixation pin was stuck in the contra angle driver.The procedure was completed without delay using another 90° contra angle driver.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# 490190) and contra angle temporary fixation screw (part# 76-0017, lot# 632390) were returned in a red biohazard bag.Visual inspection showed that the screwdriver was discolored.The temporary fix screw was significantly bent and could not be released from the screwdriver collet.The screwdriver was not disassembled due to the fact that it was returned in a biohazardous condition.Further functional tests and inspections could not be performed due to the bio hazardous state of the product.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to was 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: 0001032347-2018-00426-1.

Event Description

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

• Brand Name: RIBFIX BLU SYSTEM TEMPORARY FIXATON SCREW, CONTRA ANGLE
• Type of Device: TEMPORARY FIXATON SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7657353
• MDR Text Key: 112999008
• Report Number: 0001032347-2018-00427
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• 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: 632390
• Other Device ID Number: (01)0084106202255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1