MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM X-LOCK X-DRIVE STD BLADE 86MM; SCREWDRIVER

Model Number	N/A
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (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: 0001032347-2019-00565, 0001032347-2020-00206.Medical products: 2.0mm system 2.0mm x-lock x-drive short blade 66mm, part# 01-7694, lot# 204680, 2.0mm system x-lock x-drive std blade 86mm, part# 01-7696, lot# 684630.
Event or Problem Description
It was reported the blade would not retain screws easily.No adverse events have been reported as a result of the malfunction.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.A visual inspection was completed on the 01-7696 blade and it shows very heavy signs of use on the 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.This is the only complaint due to the lack of retention for 01-7696 lot 684630.For part 01-7696 in the previous one (1) year (from the notification date) regarding a lack of retention, there is a complaint rate of 0.3%, 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.

• Brand Name: 2.0MM SYSTEM X-LOCK X-DRIVE STD BLADE 86MM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9947777
• Report Number: 0001032347-2020-00206
• Device Sequence Number: 19615966
• Product Code: HXX
• UDI-Device Identifier: 00841036015008
• UDI-Public: 00841036015008
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-7696
• Device Lot Number: 684630
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/19/2020
• 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