MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM; PLATE, BONE

Catalog Number 04.503.225.01C

Device Problem Crack (1135)

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

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

Additional product code: (b)(4).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 china as follows: it was reported that on (b)(6) 2021, during midface fracture surgery, while inserting the screw, the screw head cross threads peeled.The screw was removed from the patient and another device was used to complete the surgery.There were no adverse consequences to the patient.Concomitant device reported: unknown screwdriver (part# unknown; lot# unknown; quantity: 1) this report is for one (1) ti matrixmidface screw self-drilling 5mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12076093
• MDR Text Key: 258664879
• Report Number: 8030965-2021-05361
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819908543
• UDI-Public: (01)07611819908543
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K050608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWDRIVER