MAUDE Adverse Event Report: SYNTHES GMBH UNIVERSAL TROCAR HANDLE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	397.211
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
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.B3: unknown when malfunction occurred.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 july 5, 2024, during routine maintenance it was found that the item didn¿t properly hold the cannula.No patient or surgical involvement.This report is for one universal trocar handle.This is report 1 of 1 for (b)(4).This complaint is linked to the below complaints (b)(4) is created to capture the allegation against product code 05.001.401.98.(b)(4) is created to capture the allegation against product code 05.000.020.(b)(4) is created to capture the allegation against product code 306.501.(b)(4) is created to capture the allegation against product code 306.502.
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.H3, h4, h6: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that universal trocar handle , the provided evidence was not sufficient to confirm the reported event of unable to assemble/disassemble.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the universal trocar handle would not contribute to the complained device issue.Based on the investigation findings, 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 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.Device history return (dhr): part # 397.211.Synthes lot # 6429959.Supplier lot # 6429959.Release to warehouse date: 11 oct 2010.Manufactured by: synthes brandywine.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.Corrected data: g1: manufacture site updated.D9: device returned.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this 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.
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: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance.The reported allegation of unable to assemble/disassemble cannot be confirmed.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was performed for the universal trocar handle with a pin gauge of a diameter of 8.00mm and enter en hold with no problem.The overall complaint was not confirmed as the observed condition of the universal trocar handle would not contribute to the complained device issue.Based on the investigation findings, 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.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).If information is obtained, that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNIVERSAL TROCAR HANDLE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1301 goshen parkway; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19851594
• Report Number: 8030965-2024-09387
• Device Sequence Number: 15043098
• Product Code: FZX
• UDI-Device Identifier: 10887587041193
• UDI-Public: (01)10887587041193(10)6429959
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,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: 397.211
• Device Lot Number: 6429959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 08/26/2024; 11/08/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 08/20/2024; 08/27/2024; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown