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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported a screw fractured and the screw fragment was left inside the patient.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem 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.
Additional 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 or Problem Description
No further event information is available at the time of this report.

• Brand Name: TRAUMAONE SYSTEM 2.0X11MM SELF-DRILLING IMF SCREW
• Common Device Name: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10999085
• Report Number: 0001032347-2020-00609
• Device Sequence Number: 3617741
• Product Code: DZL
• UDI-Device Identifier: 00841036128104
• UDI-Public: 00841036128104
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K983728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/28/2020; 09/27/2021
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 01/20/2021; 10/05/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention