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

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).Complaint sample was evaluated and the reported event was not confirmed.The product identities were confirmed.The sternalock blu system blade, sternalock (part# 73-1194, lot# 859370, 577770) were visually evaluated.Both blades showed signs of moderate use with some wear and tear at the part of the shaft that interfaces with a driver collet.There was also some minor discoloration at the tips.The blades were functionally tested by inserting them into a driver (part# 46-0008) and into a 2.4mm screw (part# 76-2410), then lifting the assembly by the screw to test the blades' retention.Both blades passed the retention test and were also able to drive the screw into a block of white oak wood.Device history record (dhr) was reviewed and no discrepancies were found.The complaint was not confirmed as the device analysis indicated that the device met specification.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.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 0001032347-2019-00024-1.

Event Description

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

• Brand Name: STERNALOCK BLU SYSTEM BLADE, STERNALOCK
• 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: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 8355492
• MDR Text Key: 137252063
• Report Number: 0001032347-2019-00067
• Device Sequence Number: 1
• Product Code: HRS
• 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: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• 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: 73-1194
• Device Lot Number: 577770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1