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

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

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

Event Date 07/03/2020

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.Distributor on behalf of facility: the user facility is foreign; therefore, a facility medwatch report will not be available.(b)(6).

Event Description

It was reported that one (1) screw could not be gripped during a procedure.The procedure was completed with other 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 is confirmed.A visual inspection was conducted on the screw and it showed significant damage at the cross-drive interface on the head of the screw.Functional testing was done for retention using a driver 01-7390 lot 048760 and bit 15-1196 lot 406650.The blade was inserted into the driver and the screw, then the assembly was lifted by the screw to verify the cross-drive feature could support the weight of the blade and driver.The screw failed this retention test.The dhr will not be reviewed as the lot number remains unknown.There are no indications of manufacturing defects.For this part (95-6104) and the previous one year (from the notification date) regarding retention failure, 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 excessive force was applied beyond what the screw is designed to encounter on the screw head during use.Potential contributing factors include using a worn or incorrect blade and incorrect alignment of the blade and screw as well as the patient¿s bone density.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: 10303809
• MDR Text Key: 202781006
• Report Number: 0001032347-2020-00321
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1