MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMANDIBLE BENDING SCREW; BONE PLATE

Catalog Number 03.503.080

Device Problem Device-Device Incompatibility (2919)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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 after bending the plate, the bending screws should be removed but it was not possible due to the holes of the plate were deformed after bending process.The removal of the bending screws was only possible by drilling.Procedure was completed successfully with thirty(30) minutes surgical delay.Patient status is fine.This report is for one (1) matrixmandible bending screw.This is report 4 of 4 for complaint (b)(4).

• Brand Name: MATRIXMANDIBLE BENDING SCREW
• Type of Device: BONE PLATE
• 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: 12869491
• MDR Text Key: 285221619
• Report Number: 8030965-2021-09758
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819979840
• UDI-Public: (01)07611819979840
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BENDING INSERT HOLDER FOR 03.503.080; MATRIXMANDIBLE BENDING SCREW; UNK - PLATES: MATRIXMANDIBLE
• Patient Weight: 70 KG