MAUDE Adverse Event Report: SYNTHES GMBH AIMING ARM/ RADIOLUCENT; NAIL, FIXATION, BONE

Catalog Number 03.043.029

Device Problem Mechanical Problem (1384)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2023 during pre-operative examination, it was noted that the clip on the aiming arm was not functioning properly.There was no patient involvement.This report is for one aiming arm/ radiolucent 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.H10 additional narrative: e1: initial reporter is j&j company representative h3, h4, h6 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 aim-arm radioluc had both locking latch tab tips broken off.Broken fragments were not returned.It is reasonable to conclude that the broken condition would make the device stop functioning as intended.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.During the analysis of the complaints two subcategories of the aiming arm (03.043.029) latch (60224287) failure were identified.The failure is a breakage of the carbon-fiber reinforced latch.The failure mode is an interlaminar breakage due to shear forces.Breakage is most likely favored by defects in the structure of the carbon fiber reinforced peek plate.It is in the nature of the material that the shear strength is highly anisotropic and lowest between carbon fiber layers.Likely interlaminar shear strength is reduced by defects resulting form manufacturing issues not leading to complete bond between the carbon layers.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 aim-arm radioluc would contribute to the complained device issue.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: part # 03.043.029; lot # 2024491; manufacturing site: selzach; supplier: (b)(4).Release to warehouse date: 15 mar 2021.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: AIMING ARM/ RADIOLUCENT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SELZACH; bohnackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17764807
• MDR Text Key: 323614401
• Report Number: 8030965-2023-11713
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982297396
• UDI-Public: (01)10886982297396
• 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

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 Catalogue Number: 03.043.029
• Device Lot Number: 2024491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1