MAUDE Adverse Event Report: BIOMET MICROFIXATION TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK 2.0MM X 5MM; PLATE, BONE

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 09/09/2020

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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00487, and 0001032347-2020-00488.Concomitant medical products: 2.0mm system twist drill with j notch 1.5mm x 105mm w/ 22mm stop, part# 01-9198, serial# (b)(4).2.0mm system twist drill with j notch 1.5mm x 105mm w/ 22mm stop, part# 01-9198, serial# (b)(4).Tms system high torque (ht) cross-drive screw, 5/pk 2.0mm x 5mm, part# 25-2005, lot# ni.Tms system high torque (ht) cross-drive screw, 5/pk 2.0mm x 7mm, part# 25-2007, lot# ni.Tms system high torque (ht) cross-drive screw,5/pk 2.3mm x 7mm, part# 25-2307, lot# ni.The user facility is foreign, therefore, a facility medwatch report will not be available.(b)(6).

Event Description

It was reported that several screws stripped during insertion attempts during a procedure for a zygomatic fracture.The pilot holes were prepared with drills, and the surgeon does not know if the drill tip or the screws are the cause of the event.The procedure was completed with an emergency screw.No adverse events were reported as a result of the malfunction.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6.Visual inspection of the returned products to verify item and lot number.Item and lot numbers could not be verified on the 4 returned screws.Cosmetic inspection of the products found wear marks, shiny spots and light scratches.Inspection of the threads and cutting flutes found no damages but do show signs of use.Dimensional analysis was performed on the returned screws and drill bits.All screws and drill bits were found to be conforming to print and inspection criteria.Medical records were not provided.A review of the device history records will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria.Product was verified within specification and no problem found.If any further information 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: TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK 2.0MM X 5MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10626185
• MDR Text Key: 209788674
• Report Number: 0001032347-2020-00486
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036089528
• UDI-Public: 00841036089528
• 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,health pr
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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: 25-2005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE