MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM CROSS DRIVE BLADE, LONG

Model Number N/A

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Complaint sample was evaluated and the reported event was not confirmed.The blades were visually evaluated and found to show some signs of use with minimal scratching on the shafts and slight wear on the cross-drive interfaces.Functional testing was done on the blades to test retention.The blades were inserted into a ratcheting driver and the cross-drive interfaces were inserted into a screw.The assembly was then lifted by the screw and the retention was verified, as the interfaces were able to support the weight of the blade and driver.The complaint is unconfirmed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the reported event was not substantiated.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: 0001032347-2019-00109-2, 0001032347-2019-00110-2, 0001032347-2019-00111-2, 0001032347-2019-00293, 0001032347-2019-00294, 0001032347-2019-00295.

Event Description

It was reported these blades were dull.This was noted during inventory inspection.There was no patient involvement.

• Brand Name: RIBFIX BLU SYSTEM CROSS DRIVE BLADE, LONG
• 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: 8636613
• MDR Text Key: 145951363
• Report Number: 0001032347-2019-00296
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00084103617759
• UDI-Public: 0084103617759
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• 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: 73-1196
• Device Lot Number: 899300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1