MAUDE Adverse Event Report: SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC 3.5MM TI VA SCR 16MM TRILEAP(TM); PLATE, FIXATION, BONE

Catalog Number	04.910.016
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent a mtp fusion case using the tri-leap set on (b)(6) 2024.There was an issue with the cup and cone reamers; the reamers not being sharp enough.The surgeon used six different reamers and said all were dull and not cutting away at the bone like they should be.The surgeon was asked if he felt like his power was high enough and he assured that it was.The doctor had to then manually remove the bone at the joint with a ronguer.The size cup reamers used in the case were 22,20, and 18.The size cone reamers used in the case were 18,16,14.There was an issue with the most medial distal plate hole.Multiple locking screws would not lock into the plate.When placing the plate, threaded olive wires and compression forceps were used to eventually gain axial compression.A coaxial drill guide screwed into the plate was used to drill for the distal medial screw.Then a 2.7 drill bit was used to drill and measured for a 14mm locking screw off of the drill bit.When putting the screw in by hand, the surgeon complained that the screw was not locking into the plate.Another 14mm locking screw was tried as well as a 16mm locking screw but with no luck.The surgeon said he was getting purchase with the threads of the shaft but as soon as the threads at the bottom of the screw head engaged with the bone it stopped advancing and kept spinning in place.Surgeon placed a non-locking screw in this hole.One of the last screws placed was the most lateral proximal screw (20mm locking) and it locked into the plate fine after all non- locking screws had been placed and the plate had been completely compressed to the bone.
Additional Manufacturer Narrative
Product complaint (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 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 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.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.
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.

• Brand Name: 3.5MM TI VA SCR 16MM 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: 20236580
• Report Number: 3020584246-2024-00014
• Device Sequence Number: 12989835
• Product Code: HRS
• UDI-Device Identifier: 00810112594843
• UDI-Public: (01)00810112594843
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2024

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: 04.910.016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 10/24/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/06/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 - DRILL BITS: TRAUMA; UNK - DRILL BITS: TRAUMA; UNK - FORCEPS; UNK - FORCEPS; UNK - PLATES: TRAUMA; UNK - PLATES: TRAUMA; UNK - SCREWS: LOCKING; UNK REAMER - CROSSROADS; UNK REAMER - CROSSROADS; UNK REAMER - CROSSROADS; UNK REAMER - CROSSROADS; UNK REAMER - CROSSROADS; UNK REAMER - CROSSROADS
• Patient Age: 40 YR
• Patient Sex: Male