MAUDE Adverse Event Report: SYNTHES GMBH AIMING ARM/ANT/F/MULTILOC PROXIMAL HUMERAL NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.019.009
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
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.H11 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) 2024, during inspection of some multiloc humeral nail instruments, it was determined that the insert-handle f/multiloc hum nail systand and the aim-arm ant f/multiloc hum nail syst, which are two components that are designed to connect securely to each other when in use, would only connect correctly when the aim-arm ant f/multiloc hum nail systwas connected to the right side of the insert-handle f/multiloc hum nail syst, not the left side.This was identified as a potential problem issue if used in surgery for a left arm, and thus these 2 items were deemed to be no longer functional.There was no patient consequence.This report involves one aiming arm/ant/f/multiloc proximal humeral nail.This is report 2 of 2 for (b)(4).
Event or Problem Description
It was further reported it was unknown when the device malfunction occurred.
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.B3: there is no exact event date; the malfunctions were discovered during inspection.It is unknown when they occurred.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The product was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that there were no damage or defect with the aim-arm ant f/multiloc hum nail syst.A functional test was performed between aim-arm ant f/multiloc hum nail syst and insert-handle f/multiloc hum nail syst, where connecting the assembly on the right side of the device showed no issues, and the assembly was appropriate.Then, an attempt was made to assemble on the left side, and it was difficult for both devices to fit together.However, the observed damage correspond to the mating device.A dimensional inspection was performed and met specifications.The overall complaint not confirmed as the observed condition of the aim-arm ant f/multiloc hum nail syst would not 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.As part of depuy synthes 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 review (dhr): part# 03.019.009; lot # l924555; manufacturing site: werk hägendorf.Release to warehouse date: 12 oct 2018.Expiration date: a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, follow-up medwatch will be filed as appropriate.

• Brand Name: AIMING ARM/ANT/F/MULTILOC PROXIMAL HUMERAL NAIL
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19731816
• Report Number: 8030965-2024-08650
• Device Sequence Number: 18190258
• Product Code: HSB
• UDI-Device Identifier: 07611819425590
• UDI-Public: (01)07611819425590(17)381017(10)L924555
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.019.009
• Device Lot Number: L924555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 07/13/2024; 08/26/2024; 09/12/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/05/2024; 09/09/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2018
• 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: INSERT-HANDLE F/MULTILOC HUM NAIL SYST
• Patient Sex: Unknown