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

Model Number	N/A
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BLADE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8636588
• Report Number: 0001032347-2019-00293
• Device Sequence Number: 2211936
• Product Code: HRS
• UDI-Device Identifier: 00841036140984
• UDI-Public: 00841036140984
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1