MAUDE Adverse Event Report: SYNTHES GMBH TI LOW PROFILE NEURO SCREW SELF-DRILLING 5MM; BONE PLATE

Catalog Number 400.835

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2023

Event Type  malfunction  

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.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10 therapy date: (b)(6) 2023.H6: 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 belgium as follows: it was reported that on (b)(6) 2023, five (5) screws could not be properly fixed during the placement, and the screw heads broke off.The screws were placed but with missing screw heads.These screws were still implanted and 2 additional screws were placed for proper fixation.This report involves one (1) ti low profile neuro screw self-drilling 5mm.This is report 5 of 5 for pc-(b)(4).

• Brand Name: TI LOW PROFILE NEURO SCREW SELF-DRILLING 5MM
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17586941
• MDR Text Key: 321717039
• Report Number: 8030965-2023-10533
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• 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: CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5; CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5; CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5; CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5
• Patient Age: 62 YR
• Patient Sex: Female