MAUDE Adverse Event Report: SYNTHES GMBH 2.0 TI MATRIXMANDIBLE SCREW STPING 14; PLATE, BONE

Model Number 04.503.414.01

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2023

Event Type  Injury  

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.Additional narrative: 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

It was reported that on (b)(6) 2023, during intra-op the screw broke halfway down the length of the threads while being inserted into the bone.The bone was pre-drilled with the proper diameter drill bit (1.5mm) full thickness of both cortex.The case was not delayed but we were not able to use the plate hole in which the screw broke since it was embedded into the bone.Patient consequences are unknown.This report is for one (1) 2.0 ti matrixmandible screw stping 14.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.0 TI MATRIXMANDIBLE SCREW STPING 14
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16586017
• MDR Text Key: 311736709
• Report Number: 8030965-2023-03503
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587020686
• UDI-Public: (01)10887587020686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.503.414.01
• Device Catalogue Number: 04.503.414.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• 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: UNK - DRILL BITS: TRAUMA; UNK - PLATES: TRAUMA
• Patient Outcome(s): Required Intervention