MAUDE Adverse Event Report: SYNTHES GMBH MULTIFUNCTION ROD FOR INSERTION INSTS; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	03.168.010
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 5/27/2024 during a procedure at the hospital with dr.Shin, they could not get the multifunction rod to thread into the aiming arm/antirotation screw.Also, because of this, they were not able to get much compression.It was unknown, if there was a surgical delay, fragments generated or the patient's outcome.No further information to report at this time.This report is for one (1) multifunction rod for insertion insts this is report 1 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese 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 synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.D9: complainant part is not expected to be returned for manufacturer review/investigation.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.The product was not returned to depuy synthes, however photos were provided for review.See attachment img_3640.Jpeg.The device associated with this report was not returned to depuy synthes for evaluation.The photographs attached were reviewed, however the image quality is poor and no observations pertaining to the nature of the reported event could be identified.Functionality of the device cannot be assessed through photo investigation, hence complaint condition cannot be confirmed.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs attached are insufficient to draw a conclusion about the reported event.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 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 lot the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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: MULTIFUNCTION ROD FOR INSERTION INSTS
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19594383
• Report Number: 8030965-2024-07817
• Device Sequence Number: 19819418
• Product Code: KTT
• UDI-Device Identifier: 10886982274519
• UDI-Public: (01)10886982274519
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• 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

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: 03.168.010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: INS F/INSERTION HANDLE; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM
• Patient Sex: Unknown