MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED TITAN 18X15X15MM IMPLANT KIT; STAPLE, FIXATION, BONE

Model Number	SE-1815TI
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The device was received, the investigation is in progess, 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.
Event or Problem Description
It was reported that on (b)(6) 2022, the doctor was operating on a patient that presented with a lisfranc fracture.The surgeon requested an se-1815ti bme staple, but the bin only had boxes of se 181815ti staples available.Upon further inspection, it was discovered that two of the boxes of se 181815ti staples actually contained se-1815ti staples inside of the implant box.The grey outer box shows se-181815ti, but the implant sticker with barcode reads se-1815ti.One of the implants was opened and it was successfully implanted with no adverse event to the patient.This report is for a speed titan 18x15x15mm implant kit.This is report 2 of 2 for (b)(4).
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.H10: additional narrative: d9, d10, h3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.H3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the speedtitan compression impl kit 18x15x15 had the package box marked as "se-181815ti" while the packslip and adhesive label both refer to "se-1815ti".A dimensional inspection for the speedtitan compression impl kit 18x15x15 was not performed due to since dimensions are not relevant to complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the speedtitan compression impl kit 18x15x15.An investigation was conducted to determine the root cause of the incorrect box being used to package this lot.The assignable cause was determined to be operator error.Jnj-nr was opened to further evaluate and determine the manufacturing error in detail that led to the complaint condition.Closure rationale pie states that the risks were analyzed, complaint search performed in qlik, transparent packaging window enabling the user to identify the correct device etc.And other multiple layers of mitigating factors that allows the correct identification of this device making it exceedingly low risk that this box printing error would ever lead to patient harm.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.H3, h6: a device history record (dhr) review was conducted: part# se-1815ti.Synthes lot# mse200139.Supplier lot# mse200139.Release to warehouse date: 12 jan2021.Expiration date: 10 jan2025.Supplier: (b)(4).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.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.

• Brand Name: SPEED TITAN 18X15X15MM IMPLANT KIT
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 14754394
• Report Number: 2939274-2022-02304
• Device Sequence Number: 1347749
• Product Code: JDR
• UDI-Device Identifier: 00810633021521
• UDI-Public: (01)00810633021521
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142292
• 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: Physician
• 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 Expiration Date: 01/10/2025
• Device Model Number: SE-1815TI
• Device Catalogue Number: SE-1815TI
• Device Lot Number: MSE200139
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 06/23/2022; 07/13/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/11/2022; 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPEEDTITAN COMPRESSION IMPL KIT 18X15X15
• Patient Sex: Unknown