MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMANDIBLE TROCAR DRILL GUIDE FOR 397.213; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.503.045
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
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.Additional narrative: event date: only the event year is known.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 or Problem Description
Device report from synthes reports an event in ireland as follows: it was reported that on an unknown date, the drill sleeve with 1.8mm drill bit was not able to pass down the low profile drilling slots on the mandible cutting guides.However, there was no issue with the drill sleeve passing through the low profile slots on the fibula guide.No further information is available.This report involves one matrixmandible trocar drill guide for 397.213.This is report 1 of 1 for (b)(4).
Event or Problem Description
There was patient involvement.However no harm was done to the patient or to the overall result of the procedure, there was a slight delay in drilling.
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.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.
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: h4, h6: part: 03.503.045.Lot: me23 - fam - tux.Release to warehouse date: 20 january 2023.Manufacturing site: materialise.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.
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.H11 additional narrative: corrected: d4 (primary udi number).Added pe code third party notification since ip added is a supplier device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will.
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.H11 additional narrative: investigation summary: event description: it appears the drill sleeve 03.503.045 (1.8mm drill bit) was not able to pass down the low-profile drilling slots on the mandible cutting guides, however there was no issue with the drill sleeve passing through the low-profile slots on the fibula guide.Although distributed by depuy synthes, (syn) the product is designed, manufactured, and labeled by the manufacturing supplier.The requirement of fda reporting, complaint investigation, root cause, and corrective action is the responsibility of the designing supplier of this item, per the supplier agreement.The product/information will be transferred to the supplier with the complaint problem statement for investigation.The results of the supplier investigation are to be populated into the depuy synthes customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process.During the investigation a planning step was reviewed.It was found that the surgeon tried to predrill with trocar using marking cylinders even it is clearly explained on case report page 8 & 9 that they are not designed for this.Date: 27 january 2023.Root cause process category: external /not materialise; user error surgeon as part of depuy synthes, quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the 03.503.045 and drillsl long f/matmand.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 lot: part: 03.503.045.Lot: me23 - fam - tux.Release to warehouse date: 20 jan 2023.Manufacturing site: materialise.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MATRIXMANDIBLE TROCAR DRILL GUIDE FOR 397.213
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16371780
• Report Number: 8030965-2023-01791
• Device Sequence Number: 6757644
• Product Code: FZX
• UDI-Device Identifier: 07611819921030
• UDI-Public: (01)07611819921030(10)ME23-FAM-TUX
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/06/2023

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: 03.503.045
• Device Lot Number: ME23 - FAM - TUX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 02/28/2023; 04/13/2023; 01/08/2026; 01/20/2026
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/07/2023; 04/19/2023; 01/09/2026; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2023
• 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: UNK - MANDIBLE CUTTING GUIDE.
• Patient Sex: Unknown