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
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10626185
• Report Number: 0001032347-2020-00486
• Device Sequence Number: 19584291
• Product Code: JEY
• UDI-Device Identifier: 00841036089528
• UDI-Public: 00841036089528
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 25-2005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/27/2020
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 08/11/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE