MAUDE Adverse Event Report: SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC MOTOBND CP NONLKNG SCR 3.5MM X 34MM STER; SCREW, FIXATION, BONE

Catalog Number	1500-3534
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
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.B3: unknown when malfunction occurred.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.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 july 3, 2024 there was a discrepancy found with packaging.Quantity 1 was received instead of qty 2 as listed on the packing list.There was no patient involvement.Issue was discovered pre-op.Inventory of items on upon receipt from loaner department.Discovered 1 item was missing.This report is for one motobnd cp nonlkng scr 3.5mm x 34mm ster.This is report 1 of 1 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.H11 additional narrative: h3, h4, h6: part:1500-3534 lot:400723 manufacturing site: crossroads extremity systems, llc supplier: na release to warehouse date:19 sep 2023 expiration date: 19 sep 2027.A manufacturing record evaluation was performed for the finished article lot and no non-conformance's were identified.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.Corrected data: d4: udi 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: MOTOBND CP NONLKNG SCR 3.5MM X 34MM 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 Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19850804
• Report Number: 3020584246-2024-00008
• Device Sequence Number: 15055133
• Product Code: HWC
• UDI-Device Identifier: 00815432025145
• UDI-Public: (01)00815432025145(11)230919(17)270919(10)400723
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173710
• 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

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: 1500-3534
• Device Lot Number: 400723
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown