MAUDE Adverse Event Report: SYNTHES GMBH AIM-ARM RADIOLUC; NAIL, FIXATION, BONE

Catalog Number 03.043.029

Device Problems Break (1069); Crack (1135)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in australia as follows: it was reported during a procedure on (b)(6) 2023, the aiming arm broke.This was a loan tibial nail advance set used for a suprapatella case at hospital.Surgeons followed the surgical technique correctly.After attaching the aiming arm to the insertion handle the latch cracked and broke.This meant the aiming arm could not securely latch on to the insertion handle.Patient procedure went ahead with no impact to patient.No surgical delay.Procedure completed successfully.This report is for aim-arm radioluc 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: h3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.D9: device returned.H3, h4, h6: 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 the aim-arm radioluc [03.043.029/2025454] had both of the hooks of the latch broken, fragments were not returned.No other issues were found.No cracks were observed.The device has signs of normal use/wear and no evidence of hammer marks were observed, therefore, a potential cause cannot be established with the provided information due to be a multifactorial issue.The semi-extended parapatellar approach surgical technique guide was reviewed.Following relevant statements were found.Precautions: ensure that the connection between the nail and the insertion handle is tight.Retighten if necessary, after hammering and prior to the attachment of the aiming arm.Do not attach the aiming arm to the insertion handle at this point.Do not exert forces on the aiming arm.These forces may prevent breakage of the device.Based on the investigation findings, the primary cause was related to the users hammering with the aiming arm in place or actually hitting on the aiming arm.A dimensional inspection for the aim-arm radioluc [03.043.029/2025454] was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the aim-arm radioluc [03.043.029/2025454] would contribute to the complained device issue 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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review (dhr): part# 03.043.029.Lot # 2025454.Manufacturing site: createc gmbh & co.Kg.Supplier: na.Release to warehouse date: 07-jun-2021.Expiration date: na.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.H4: manufacture date updated.

• Brand Name: AIM-ARM RADIOLUC
• 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: 18293479
• MDR Text Key: 330463109
• Report Number: 8030965-2023-15540
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K201336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• 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: 2025454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female