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

Catalog Number 03.043.029

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2024

Event Type  malfunction  

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.D2b: additional product code: hwc.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.H3, h4, 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.

Event Description

It was reported that on march 6, 2024, a screw targeting device from the tibial nail advanced and the clamp on that targeting device behind it both broke during insertion.There was a surgical delay of 5 minutes.The surgery was successfully completed.The patient status or outcome was reported as surgery completed.This report is for one (1) aiming arm/ radiolucent this is report 1 of 1 for complaint (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 subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H3, h4, h6: part: 03.043.029, lot: 2026781, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: 01 oct 2021, expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformance's were identified.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 had both hooks of the latch broken.The broken fragments was not returned.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 a dimensional inspection for the device was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the aim-arm radioluc would contribute to the complained device issue.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 reported 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 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.G1: manufacturing site name and address.

• 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): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18952509
• MDR Text Key: 338587207
• Report Number: 8030965-2024-03942
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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: 2026781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2021
• 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: UNK - GUIDES/SLEEVES/AIMING.; UNK - SCREWS: TRAUMA.
• Patient Age: 29 YR
• Patient Sex: Male