MAUDE Adverse Event Report: SYNTHES GMBH SYNFIX EVOLUTION AIMING DEVICE HOLDER; IMPACTOR

Model Number 03.835.004

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported during an inspection at the loaner set department at loc umkirch on (b)(6) 2022, it was noticed that the synfix evolution aiming device holder was jammed.The items has only been used 1 times.No surgery impact.No patient impact.This is report 1 of 1 for (b)(4).This report is for the synfix aiming device holder.

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.Additional narrative: unknown when malfunction occurred investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the synfix evolution aiming device holder.A dimensional inspection for the synfix evolution aiming device holder was not performed since is not applicable to the complaint condition.A functional test was performed, but the device was stuck and it was very difficult to disassemble the sleeve from the core part.The complaint condition was able to be replicated.According to event description, the device has been used only 1 time, it is probable that the device was not used as intended or mated with devices that are not within the instructions for use.The synfix® evolution secured spacer system surgical technique was reviewed.Following relevant statement was found.Instructions of use: assemble the aiming device holder according to the disassembly and assembly instructions (see page 57).Fully engage the coupling screw in the aiming device with the coupling.Attach the aiming device holder to the aiming device by pulling the outer shaft on the aiming device holder towards the handle and then engage the aiming device (1).Align the vertical black lines on the aiming device holder and the aiming device.Release the outer shaft to lock the assembly.Insert the coupling in the aiming device holder (2).Note: ensure the aiming device holder is fully seated on the aiming device (3).Warning: do not use the screwdriver without appropriate aiming device.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the synfix evolution aiming device holder would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? yes, reviewed dimensional inspection: n/a device history review part number: 03.835.004 lot number: 70p4852 manufacturing site: haegendorf release to warehouse date: 30.09.2020 a manufacturing record evaluation was performed for the finished device lot number, 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNFIX EVOLUTION AIMING DEVICE HOLDER
• Type of Device: IMPACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; GM 4614
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16409229
• MDR Text Key: 309889012
• Report Number: 8030965-2023-02061
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10705034814100
• UDI-Public: (01)10705034814100
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 03.835.004
• Device Catalogue Number: 03.835.004
• Device Lot Number: 70P4852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1