MAUDE Adverse Event Report: BIOMET MICROFIXATION TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK 2.0MM X 7MM; PLATE, BONE

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2020

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 the grip of the screw was weak and it fell off during an oral surgery procedure.The feel of the screw was described as clearly different from other screws at the time of gripping.The procedure was completed with another screw.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.A visual inspection was conducted on the screw.The screw has signs of use on the screw head and screw shaft.A dimensional analysis was unable to be completed due to marking of screw head interface threads.The complaint is confirmed.A determination cannot be made as to what caused the screw head damage.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.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

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

• Brand Name: TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK 2.0MM X 7MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10896403
• MDR Text Key: 218958734
• Report Number: 0001032347-2020-00590
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036089405
• UDI-Public: 00841036089405
• 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: 06/11/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 25-2007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1