MAUDE Adverse Event Report: SYNTHES GMBH INSERTION HANDLE/ RADIOLUCENT LONG; NAIL, FIXATION, BONE

Catalog Number 03.043.024

Device Problem Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 03/27/2024

Event Type  malfunction  

Event Description

It was reported, that on (b)(6) 2024.While performing, a suprapatellar tibial nail advancement, the targeting arm for the proximal locking screws missed the nail.Under x-ray, it was obvious, that the drill was missing the desired path of the medial- to- lateral static locking hole.After the procedure was finished, the targeting arm was tested again and the drill was still missing the nail.It was unsure if the targeting arm or the insertion handle was the issue in the system, so both will be replaced.The procedure was successfully completed with no surgical delay.This report is for one aiming arm/ radiolucent.This is report 2 of 2 for (b)(4).

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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

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.H3, h4, h6 investigation summary: 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.Device history review (dhr): part number: 03.043.024-us.Lot number: 718p898.Manufacturing site: hägendorf.Release to warehouse date: 30-may-2022.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Corrected data: b5 - event description updated.H4: manufacture date updated.G1: manufacture site updated.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 Description

It was further reported that the only patient consequence for this case was that the anterior to posterior locking screw was used instead of the medial to lateral locking screw due to the aiming arm missing.

• Brand Name: INSERTION HANDLE/ RADIOLUCENT LONG
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 19104997
• MDR Text Key: 340905583
• Report Number: 8030965-2024-05086
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982297235
• UDI-Public: (01)10886982297235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.043.024
• Device Lot Number: 718P898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AIMING ARM/ RADIOLUCENT