MAUDE Adverse Event Report: SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC 3.5MM ANTI-DRIFT BOLT F THRDD 38MM, STER; SCREW, FIXATION, BONE

Catalog Number	15FT-3538
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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: the expiration date is currently not available.Therefore, 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.
Event or Problem Description
It was reported that the user's hardware broke within a couple months of being placed.The user required a second surgery to remove the hardware.Pieces of hardware were left in the user's foot.
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.H11 additional narrative: 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.
Event or Problem Description
Updated event description: it was reported that on (b)(6) 2023, the patient presented painful bunion deformity on the left foot.On (b)(6) 2023, the patient underwent lapidus bunionectomy via first metatarsocuneiform arthrodesis with akin osteotomy.On (b)(6) 2024, the patient experienced left midfoot pain.X-rays were taken and it was discovered that the antidraft bolt placed on her initial surgery in 2023 had broken with a piece of the screw embedded into the base of the second metatarsal.On (b)(6) 2024, the patient underwent a removal surgery due to mechanical breakdown of internal fixation device of bones of foot.Doi: (b)(6) 2023, dor: (b)(6) 2024, left foot.
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: a1, a2 (dob), b5, b6, b7, d6a, d6b, d10, e1 (initial reporter facility name), h4, h6 (health effect - clinical code & medical device problem code).Corrected: b3, d4 (primary udi number).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.Device history lot a manufacturing record evaluation was performed for the finished device.Product code: 15ft-3538 lot number: 502063 the product was released on: 11 nov 2022 manufacturing site: crossroads expiry date: 25 oct 2026 no nonconformances / manufacturing irregularities were identified during the manufacturing process.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: 3.5MM ANTI-DRIFT BOLT F THRDD 38MM, STER
• 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 (Section G): CROSSROADS EXTREMITY SYSTEMS, LLC; 6423 shelby view dr.; suite 101; memphis TN
• Manufacturer Contact: angela marik ; 6423 shelby view dr.; suite 101; memphis, TN ; 9012218406
• MDR Report Key: 21178098
• Report Number: 3020584246-2025-00014
• Device Sequence Number: 11837477
• Product Code: HWC
• UDI-Device Identifier: 00815432029587
• UDI-Public: (01)00815432029587(17)261025(10)502063
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 15FT-3538
• Device Lot Number: 502063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 01/29/2025; 02/26/2025; 04/21/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/07/2025; 03/23/2025; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DYNABUNION PLATE, 18MM, LEFT, STERILE; HIMAX IMPLANT 18MM X 18MM X 18MM STER; MOTOBND CP NONLKNG SCR 3.5MM X 20MM STER; MOTOBND CP NONLKNG SCR 3.5MM X 22MM STER; MOTOBND CP NONLKNG SCR 3.5MM X 22MM STER; MOTOCLIP FUSION SYSTEM 10MM X 10MM STER; UNK PLATE - CROSSROADS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female