MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.0X11MM SELF-DRILLING IMF SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a screw fractured and the screw fragment was left inside the patient.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 a screw fractured and the screw fragment was left inside the patient¿s mandible.No x-rays or treatment were required.It was reported that no further information is available.

Manufacturer Narrative

Quantity of one 2.0 x 11mm sd imf hex screw was returned for evaluation.Visual examination identified the device to be fractured.However, not all fractured pieces were returned.A fragment of the screw was left in the patient with no intervention/attempt to remove.Review of the device history records identified no deviations or anomalies during manufacturing.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: TRAUMAONE SYSTEM 2.0X11MM SELF-DRILLING IMF SCREW
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10999085
• MDR Text Key: 221240332
• Report Number: 0001032347-2020-00609
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00841036128104
• UDI-Public: 00841036128104
• Combination Product (y/n): N
• PMA/PMN Number: K983728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 91-5611
• Device Lot Number: J190580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/13/2020
• Supplement Dates Manufacturer Received: 12/28/2020; 09/27/2021
• Supplement Dates FDA Received: 01/20/2021; 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention