MAUDE Adverse Event Report: SYNTHES GMBH LOW PROFILE NEURO SCRWDRVR BLD SLF-RETAIN/CRUCIFORM/MED/HXC; SCREWDRIVER

Catalog Number	313.932
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
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.H10 additional narrative: h3, h4, h6 investigation summary 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 the cruciform tip of the label-clip f/313.932 was worn/stripped.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed conditions of label-clip f/313.932 would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history part:313.932, synthes lot:um31081, supplier lot: um31081, release to warehouse date: jan 08,2004, supplier: (b)(4).Ncrs were generated during production.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, surgeon was trying to plate the cranial flap and the matrix neuro screws started stripping.Surgeon thought that either the screws are defective or that the screw driver shafts are defective.Screws collected along with the screwdriver shafts and put in aa specimen cup to be sent in.It is unknown if there was a surgical delay.The surgery was successfully completed.This report is for one low profile neuro screwdriver bld slf-retain/cruciform/med/hxc for complaint (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.H12 corrected data previous initial report mwr-09052024-0001632316 (mrn 8030965-2024-06114) was not late.The previous alert and submission dues were incorrectly submitted.The alert date for the impacted product was may 7, 2024.That is the date the evaluation was completed and the malfunction was determined.The appropriate submission due date was june 6, 2024 for the initial report.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.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.H12 corrected data previous initial report mwr-09052024-0001632316 (mrn 8030965-2024-06114) was not late.The previous alert and submission dues were incorrectly submitted.The alert date for the impacted product was (b)(6) 2024.That is the date the evaluation was completed and the malfunction was determined.The appropriate submission due date was (b)(6) 2024 for the initial report.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: LOW PROFILE NEURO SCRWDRVR BLD SLF-RETAIN/CRUCIFORM/MED/HXC
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19286975
• Report Number: 8030965-2024-06114
• Device Sequence Number: 12666578
• Product Code: HXX
• UDI-Device Identifier: 10887587037059
• UDI-Public: (01)10887587037059
• 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

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: 313.932
• Device Lot Number: UM31081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LABEL-CLIP F/313.932; MATRXNEUR SCRDRVR BLD HEX CPL/SLFRET/MD; MATRXNEUR SCRDRVR BLD HEX CPL/SLFRET/MD; TI MATRIXNEURO SCREW SELF-DRILLING 4MM; TI MATRIXNEURO SCREW SELF-DRILLING 4MM
• Patient Sex: Female