MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK; PLATE, BONE

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 09/24/2020

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 screw could not be gripped during a procedure for a zygomatic fracture.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.Visual inspection was conducted on the returned screw.The screw show signs of wear/ damage to screw head.Further evaluation shows that the cross face interface of the screw is stripped as a result of the damage and will not allow for retention.The complaint is confirmed.A determination cannot be made as to what caused the screw head wear/ 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: 1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10673184
• MDR Text Key: 211296308
• Report Number: 0001032347-2020-00509
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036056155
• UDI-Public: 00841036056155
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• 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: 95-1504
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1