MAUDE Adverse Event Report: SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC 1ST MTP TI FUSN PL SM 0 D LF TRILEAP(TM); PLATE, FIXATION, BONE

Catalog Number	04.900.001
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, the locking screws would not engage the plate despite attempts made to troubleshoot the issue.The physician became frustrated with the trileap locking system and elected to use a legacy va foot mtp plate instead.The triplead plate is available for return with this complaint the screws are not.
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: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.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
Additional information received states that this was an intraoperative event.
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: 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: added: h4.H3, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample found the 1st mtp ti fusn pl sm 0 d lf trileap(tm) stripped near the holes that the screws must be inserted, this condition can be a trigger to not assemble into the mating devices.While no root cause can be established with the available information, factors such issues during the surgical process.Could have stripped the implant.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection was not performed due to post manufacturing damage.A functional test was not performed due to the mating devices were not returned for evaluation as part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 1st mtp ti fusn pl sm 0 d lf trileap(tm) would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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 review: product code: 04.900.001.Lot number: 2023005439.Release to warehouse date: june 27, 2024.Expiration date: 31 dec 2041.Manufacturing site: crossroad extremity-hg medical gmbh.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: 1ST MTP TI FUSN PL SM 0 D LF TRILEAP(TM)
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21265357
• Report Number: 3020584246-2025-00022
• Device Sequence Number: 4275894
• Product Code: HRS
• UDI-Device Identifier: 00810112595574
• UDI-Public: (01)00810112595574(17)411231(10)2023005439
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K230591
• 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
• Report Date (Section B): 01/29/2025

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: 04.900.001
• Device Lot Number: 2023005439
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 02/06/2025; 03/04/2025; 08/06/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/13/2025; 03/11/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown