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

Model Number N/A

Device Problem Misconnection (1399)

Patient Problem No Information (3190)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product - unknown biomet microfixation blade catalog #: ni, lot #: ni.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).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.

Event Description

It was reported that there was weak gripping at the screw-head.No adverse events have been reported as a result of the malfunction.

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.Complaint sample was evaluated and the reported event was confirmed.The screw was visually evaluated and found to show signs of use.The screw showed significant damage at the cross-drive interface on the head of the screw.Functional testing was done for retention using a driver and blade.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, therefore, the complaint is confirmed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to excessive force being applied beyond what the screw is designed to encounter on the screw head during use.Potential contributing factors are using a worn or incorrect blade and incorrect alignment of the blade and screw.The ifu for this screw (ifu for cranial plating (01-50-1540) revb) states in the section titled 'bone screws': the screwdriver, which has been designed, for a particular system of screws must always be used to be sure that proper screwdriver/screw head connection is achieved.Incorrect alignment or fit of the screwdriver to the screw head may increase the risk of damage to the implant or screwdriver.Excessive torque can cause the screw to fracture.A summary of the investigation has been sent to the complainant.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: THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8523850
• MDR Text Key: 142252888
• Report Number: 0001032347-2019-00235
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036134808
• UDI-Public: 00841036134808
• Combination Product (y/n): N
• PMA/PMN Number: K121624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 07/08/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1