MAUDE Adverse Event Report: BIOMET MICROFIXATION 90 DEGREE CONTRA ANGLE SCREWDRIVER

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Device Inoperable (1663); Separation Failure (2547)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient sex - no information was checked in error as there is no patient involvement.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2017-00881.

Event Description

It was reported that while preparing for a product demonstration the sales distributor identified it is almost impossible to load the blades or temporary fixation pins in the driver.If you are able to get a blade/pin loaded in the driver, then you struggle to remove the blade/pin.One of the drivers won¿t turn when blade/pin is loaded.No patient involvement.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned and no functional tests or inspections could be performed.For these reasons, the complaint could not be verified and the most likely underlying cause of the complaint could not be determined.Device history record (dhr) review was unable to be performed as the lot numbers of the devices involved in the event are unknown.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 report: 0001032347-2017-00881-1.

• Brand Name: 90 DEGREE CONTRA ANGLE SCREWDRIVER
• Type of Device: SCREWDRIVER
• 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: 7113923
• MDR Text Key: 95744134
• Report Number: 0001032347-2017-00880
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

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
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 24-1189
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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