MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 1.7MM X 7MM TI SELF DRILLING IMF SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 11/16/2020

Event Type  Injury  

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.

Event Description

It was reported that two (2) screws fractured and there was a sixty (60) minute delay while the fractured shafts of the screws were removed from the patient.The patient did not have a catheter at the beginning of the surgery, and a catheter was put in after the screw fractures as the surgeon realized the surgery would take longer than anticipated.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that two (2) screws fractured and there was a sixty (60) minute delay while the fractured shafts of the screws were removed from the patient.The patient did not have a catheter at the beginning of the surgery, and a catheter was put in after the screw fractures as the surgeon realized the surgery would take longer than anticipated.The screws were removed by cutting away bone and tissue around the broken screw in order to make enough room for wire drivers to grab onto the end and twist it out.No additional patient consequences have been reported.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A visual inspections of the returned screws show heavy signs of use.The screws have both fractured where the screw threads meet the screw head.The complaint is confirmed.A determination cannot be made as to what caused the screws to fracture.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.

• Brand Name: TRAUMAONE SYSTEM 1.7MM X 7MM TI SELF DRILLING IMF SCREW
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10927151
• MDR Text Key: 218919763
• Report Number: 0001032347-2020-00593
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00841036194390
• UDI-Public: 00841036194390
• Combination Product (y/n): N
• PMA/PMN Number: K983728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SP-3236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention