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

Model Number N/A

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Unique identifier (udi) number: (b)(4).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: 0001032347-2019-00022 through 0001032347-2019-00023.

Event Description

It was reported the blade is dull.No adverse events have been reported as a result of the malfunction.

Event Description

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

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.The product identity could not be confirmed due to the product not being returned.The sternalock blu system blade, sternalock powerdriver (part# 73-1191, lot# unk) could not be visually evaluated or functionally tested due to the product not being returned and no photos being provided by the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are no indications of manufacturing defects.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.The following sections were updated: date received by manufacturer.Pma/510(k) number corrected from k110574 and k161896 multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00021-1, 0001032347-2019-00022-1, 0001032347-2019-00023-1, and 0001032347-2019-00067.

• Brand Name: STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER
• Type of Device: BLADE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8233105
• MDR Text Key: 132586492
• Report Number: 0001032347-2019-00024
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K161896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-1191
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1