MAUDE Adverse Event Report: BIOMET MICROFIXATION THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM; PLATE, BONE

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).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.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source - (b)(6).

Event Description

It was reported two (2) screws were stripped and could not be used.The procedure was completed with alternate screws.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.The complaint cannot be confirmed.A visual and functional inspection could not be conducted due to products being lost post receipt.There will be no dhr review as the lot number remains unk.There are no indications of manufacturing defects.For this part (91-6704) and the previous one year (from the notification date) regarding the screws having a poor 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 could not be determined due to the product being lost post receipt.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.

• Brand Name: THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10115387
• MDR Text Key: 193953798
• Report Number: 0001032347-2020-00256
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036134808
• UDI-Public: 00841036134808
• Combination Product (y/n): N
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

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: 91-6704
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1