MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM 2.0MM X-LOCK X-DRIVE SHORT BLADE 66MM; SCREWDRIVER

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).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.The product remains implanted in the patient, but a revision may occur at a later unspecified date at which time the device may be returned for testing.Medical products: unknown screws, part# unknown, lot# unknown.

Event Description

It was reported the blade would not retain screws easily.There was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.A visual inspection was completed on the 01-7694 blade and it shows very heavy signs of use on blade and the cross-drive interface.The blade was functionally tested for retention using a ratcheting screwdriver (part# 46-0008) and a 2.0mm test screw.The blade was inserted into the driver, then the driver + blade assembly was inserted into the screw and the full assembly was lifted by the screw.The cross-drive interface of the blade was unable to support weight of the driver.The non-conformance database was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.The is the only complaint due to the lack of retention for 01-7694 lot 204680.For part 01-7694 in the previous one (1) year (from the notification date) regarding a lack of retention, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is wear due to repeated use.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.

Event Description

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

Manufacturer Narrative

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

Event Description

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

• Brand Name: 2.0MM SYSTEM 2.0MM X-LOCK X-DRIVE SHORT BLADE 66MM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9512944
• MDR Text Key: 191698194
• Report Number: 0001032347-2019-00565
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-7694
• Device Lot Number: 204680
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/17/2019; 05/11/2020
• Supplement Dates FDA Received: 04/13/2020; 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE