MAUDE Adverse Event Report: SYNTHES GMBH MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT

Catalog Number	03.503.016
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional 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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D10: date of concomitant therapy is (b)(6) 2024.H3, h4, 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 or Problem Description
It was reported that on (b)(6) 2024, during a craniotomy the heads of the screws in question stripped while being inserted with the short screwdriver blades.The screwdriver blades were switched to the longer blades and the screws were able to be inserted successfully.The procedure was completed successfully with an unknown surgical delay.There was no reported adverse patient impact.No further information is available.This report is for a matrixneuro screwdriver blade hex coupling/self-retain/short.This is report 2 of 2 for (b)(4).
Additional 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.H6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that had signs of corrosion on the tip of the device.It can be observed signs of normal use.Therefore the reported allegation cannot be confirmed.A functional test was performed for the matrxneur scrdrvr bld hex cpl/sf-ret/sht and assemble with the screw head ti matrixneuro screw self-drilling 4mm with no issue.The returned sample pass the test.The overall complaint was unconfirmed as the observed condition of the matrxneur scrdrvr bld hex cpl/sf-ret/sht would contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H6: device history record (dhr) review conducted: part # 03.503.016; synthes lot # ur76508; supplier lot # ur76508.Release to warehouse date: 18 may 2017.Supplier: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.

• Brand Name: MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT
• Common Device Name: SCREWDRIVER
• 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: 18849829
• Report Number: 8030965-2024-03314
• Device Sequence Number: 20697373
• Product Code: HXX
• UDI-Device Identifier: 10887587011547
• UDI-Public: (01)10887587011547
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.503.016
• Device Lot Number: UR76508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 03/07/2024; Not provided
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/21/2024; 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MATRXNEUR SCRDRVR BLD HEX CPL/SF-RET/SHT; TI MATRIXNEURO SCREW SELF-DRILLING 4MM; TI MATRIXNEURO SCREW SELF-DRILLING 4MM; TI MATRIXNEURO SCREW SELF-DRILLING 4MM; TI MATRIXNEURO SCREW SELF-DRILLING 4MM
• Patient Sex: Unknown