MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIM-ARM RADIOLUC; SCREW, FIXATION, BONE

Catalog Number 03.043.029

Device Problem Break (1069)

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

Event Date 05/22/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in the usa as follows: it was reported that on an unknown date, while it was trying to take off the aiming arm from the insertion handle, the aiming arm was broken from the tibial nail advanced set.Replacement needed.There was no patient involvement.This complaint involves one (1) device aim-arm radioluc.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Additional narrative: additional product code: jds.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter occupation: reporter is a j&j sales representative.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.

Event Description

It was further reported that this occurred during evaluation.While demonstrating how the aiming arm latched onto the insertion handle and when taking it off, a part of the hook snapped off.There was no case involvement.

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.H6: device photo investigation: the photo was returned to depuy synthes for evaluation.Visual analysis of the photo revealed that the aim-arm radioluc appears to be broken from one of the hooks from the latch.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 the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the aim-arm radioluc.Jnj nr and capa are opened to further determine the manufacturing/process error that cause the complaint condition.Any further corrective/preventive actions if required will be determine under nr and capa.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.H6: a device history record (dhr) review was conducted: part # 03.043.029.Lot # 2024490.Manufacturing site: createc gmbh.Supplier: (b)(4).Release to warehouse date: 26 march 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.

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.D9, g3: device returned on 21-july-2022.G6: follow up #2.H6: investigation completed.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 was found to be broken from one of the two hooks, fragment was not returned in the provided evidence.A dimensional inspection for the aim-arm radioluc was unable to be performed due to post manufacturing damage and complex geometry of the 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 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.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.

• Brand Name: AIM-ARM RADIOLUC
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• 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: 14746789
• MDR Text Key: 303227351
• Report Number: 2939274-2022-02293
• Device Sequence Number: 1
• Product Code: HNC
• UDI-Device Identifier: 07612334171108
• UDI-Public: (01)07612334171108
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2022

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: 2024490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 07/11/2022; 07/21/2022
• Supplement Dates FDA Received: 07/19/2022; 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2021
• 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