MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM; SCREW FIXATION INTRAOSSEOUS DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number 04.503.225.01C

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional procode: jey.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during a maxillofacial fracture procedure, the matrix midface self-drilling screw cracked during insertion.The screw was removed from the patient.There was no patient consequence.The procedure was completed using another matrix midface self-drilling screw.There is no further information available.This report is for one (1) ti matrixmidface screw self-drilling 5mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.B5.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

There was no surgical delay.Concomitant device: unknown insertion instrument (part# unknown, lot# unknown, qty 1).

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12069868
• MDR Text Key: 258467546
• Report Number: 8030965-2021-05329
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819908543
• UDI-Public: (01)07611819908543
• Combination Product (y/n): N
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.225.01C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS: TRAUMA