MAUDE Adverse Event Report: SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC 3.0MM TI VA SCR 12MM TRILEAP(TM); SCREW, FIXATION, BONE

Catalog Number	04.908.012
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent an unknown procedure on (b)(6) 2024.Locking screws of all sizes would not lock into the mtp plates.Locking screw heads would not engage with the locking threads in the plate.Screw is hitting near cortex before sitting low enough to engage.This was tried multiple times with different plates and screws.Procedure was completed successfully with an unknown delay.Patient has prominent hardware.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.
Event or Problem Description
Additional information received: a.What is the timing of the reported event? (pre-op, intra-op, post-op) - intra-op.B.Was there a patient involvement? (yes or no): yes.C.Please indicate the event details that are associated with tyber medical¿s product.Locking screw heads would not engage with the locking threads in the plate.Screw is hitting near cortex before sitting low enough to engage.This was tried multiple times with different plates and screws.Trainers have recommended drilling through the near cortex so that the screw can sit down far enough, indicating a large design flaw.D.Is there any implication towards the device (04.354.222)? was the associated device used in a locking hole for fixation? yes.E.Intra-op: was there a surgical delay in relation to the reported event? yes.F.Was other medical intervention required? no.G.Are you able to confirm if the 04.354.222 screw was used to fixate the plate, or if it was just used as an accessory in the surgery? fixate plate.
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.H11 additional narrative: added: b5 and h6 (health effect - impact code).If information is obtained that was not available for the initial report, a follow-up report 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.H3, h6: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.0MM TI VA SCR 12MM TRILEAP(TM)
• Common Device Name: SCREW, 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: 21070382
• Report Number: 3020584246-2025-00006
• Device Sequence Number: 16991884
• Product Code: HWC
• UDI-Device Identifier: 00810112594300
• UDI-Public: (01)00810112594300
• Combination Product (Y/N): N
• 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

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: 04.908.012
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 03/24/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/20/2025; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown