MAUDE Adverse Event Report: SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC MOTOCLIP INSERTER, 10MM; STAPLE, FIXATION, BONE

Catalog Number	100024
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
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.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 a part of the motoclip staple inserter broke while deploying the staple during the case; a fragment was generated.The surgeon was able to finish the case successfully with no surgical delay; it is unknown if there were patient consequences.
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: corrected: d4 (lot, primary udi number).Recaptured codes on h6 (medical device problem code).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: d9 h3, 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.H11 additional narrative: corrected: h6 (health effect - clinical code, impact code), medical device problem code removed foreign body and embedded codes.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, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation and send to the supplier for further investigation.Note: please see attachment ¿supplier reports complaint investigations for (b)(4) and (b)(4) completed crossroads follow up september 2025 week 38¿ for report details.Upon review of the returned product, one of the three pins is not attached.Due to the re use of the instrument it is undetermined how or why the pin is not attached to the hole as intended.Due to the reuse of the instrument, it is undetermined how or why the pin is not attached to the hole as intended.Upon investigation, it has been determined the breakage of the inserter is recorded as a failure listed as a moderate risk in the supplier internal documentation a functional test was not performed due to post manufacturing damage.A dimensional inspection was not performed due to it is not applicable to the complaint condition the overall complaint was confirmed as the observed condition of the motoclip inserter, 10mm would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition hence a root cause can be end of life.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: review of the manufacturing report revealed there are no anomalies or deviations with the reported batch of the motoclip staple inserter, 10 mm.Part # 100024; synthes lot # 607758; supplier lot # (b)(4); release to warehouse date: 10 sep 2024; supplier: (b)(4).No ncr's generated during production.Device history review: 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.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.H11 additional narrative: h3, h6: the product was returned to j&j medtech orthopaedics for evaluation and send to the supplier for further investigation.Upon review of the returned product, one of the three pins is not attached.Due to the re use of the instrument it is undetermined how or why the pin is not attached to the hole as intended.Due to the reuse of the instrument, it is undetermined how or why the pin is not attached to the hole as intended.Upon investigation, it has been determined the breakage of the inserter is recorded as a failure listed as a moderate risk in the supplier internal documentation a functional test was not performed due to post manufacturing damage.A dimensional inspection was not performed due to it is not applicable to the complaint condition the overall complaint was confirmed as the observed condition of the motoclip inserter, 10mm would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition hence a root cause can be end of life.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: review of the manufacturing report revealed there are no anomalies or deviations with the reported batch of the motoclip staple inserter, 10 mm.Part # 100024.Synthes lot # 607758.Supplier lot # 607758.Release to warehouse date: 10 sep 2024.Supplier: (b)(4).No ncr's generated during production.Device history review: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MOTOCLIP INSERTER, 10MM
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 21883537
• Report Number: 3020584246-2025-00031
• Device Sequence Number: 7899953
• Product Code: JDR
• UDI-Device Identifier: 00810112597820
• UDI-Public: (01)00810112597820(10)607758
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142727
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,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: 100024
• Device Lot Number: 607758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 10/24/2025; 11/03/2025; 12/15/2025; 12/29/2025; 02/06/2026
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 10/27/2025; 11/18/2025; 12/15/2025; 01/01/2026; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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
• Patient Sex: Unknown