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
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
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.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10896403
• Report Number: 0001032347-2020-00590
• Device Sequence Number: 14215185
• Product Code: JEY
• UDI-Device Identifier: 00841036089405
• UDI-Public: 00841036089405
• 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): 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
• Operator of Device: 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 Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 06/11/2021
• 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