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 #: 056380; biomet microfixation ribfix blu system 90° contra angle driver catalog #: 24-1189, lot #: 056370.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 reports: 0001032347-2018-00422 and 0001032347-2018-00423.

Event Description

It was reported two (2) 90 degree screwdrivers have short temporary fixation screws stuck inside.The patient was not injured and there was no delay in the case.The procedure was completed using backup 90 degree screwdrivers.The case ended well.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# 056380 (qty 1), lot# 056370 (qty 1)) and the contra angle temporary fixation screw (part# 76-0017, lot# 828490 (qty 2)) were visually evaluated.The bodies and heads of the screwdrivers were discolored.The temporary fixation screws appeared to be in good condition, but the interfaces between the screws and the screwdrivers were also discolored.The screwdrivers were functionally tested by rotating the knob in both clockwise and counterclockwise directions.The screwdriver from lot# 056370 had minimal sticking during rotation and was squeaking.The screwdriver from lot# 056380 was completely seized and could not be rotated.Neither screwdriver would release the temporary screw from the collet.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event 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 reports: 0001032347-2018-00422-1 and 0001032347-2018-00423-1.

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: 7656499
• MDR Text Key: 113004396
• Report Number: 0001032347-2018-00424
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

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: 828490
• Other Device ID Number: (01)0084106202255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1