MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

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 confirmed.The blades were visually evaluated and found to have some slight brownish residue present.The residue was not able to be wiped away with alcohol and a wipe.The complaint is confirmed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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, 0001032347-2019-00294, 0001032347-2019-00295, 0001032347-2019-00296.

Event Description

It was reported this item was dull and rusted.This was noted during inventory inspection.There was no patient involvement.

• Brand Name: STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER
• 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: 8636588
• MDR Text Key: 145946333
• Report Number: 0001032347-2019-00293
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036140984
• UDI-Public: 00841036140984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161896
• 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: 73-1191
• Device Lot Number: 194960
• 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: 02/21/2017
• 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