MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM RADIOLUCENT; ROD,FIXATION,INTRAMEDULLARY

Model Number 03.233.006

Device Problems Crack (1135); Device-Device Incompatibility (2919)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional narrative: event year is reported as 2021; however exact date of event is unknown.Additional product code: hwc complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Customer quality investigation: the device was not returned.A photo-investigation was performed on the images.Upon inspecting the images provided, a crack was observed on the latch of the device.The root cause of the crack cannot be determined based on the available images.A functional assessment was not able perform since the device was not returned.However, the cracked condition of the latch could have contributed to the device interaction issue 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.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot.Part number: 03.233.006.Lot number: 81p2259.Manufacturing site: (b)(4).Release to warehouse date: january 18, 2021.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.

Event Description

It was reported that on an unknown date, the patient underwent for a surgery.During the surgery, when connecting the aiming arm radiolucent to the unknown insertion device, the connection piece cracked.There was no surgical delay.The procedure was successfully completed.There was no patient consequence reported.Concomitant device reported: unknown insertion device (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) aiming arm radiolucent.This report is 1 of 1 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.A product investigation was completed: during the analysis of the device two subcategories of the aiming arm latch 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 from manufacturing issues not leading to complete bond between the carbon layers.A functional inspection was not performed as the mating device was not available.It cannot be confirmed that the device is unable to assemble with its mating device.A dimensional inspection was not performed due to the complex geometry of the part.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed; no design issues or discrepancies were identified.The complaint was confirmed.The root cause of the complaint condition can be confirmed as the manufacturing/processing error with the carbon fiber layers.Relevant actions have been taken to address the issue.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: AIMING ARM RADIOLUCENT
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12601565
• MDR Text Key: 284018814
• Report Number: 2939274-2021-05988
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982288363
• UDI-Public: (01)10886982288363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201346
• 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
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.233.006
• Device Catalogue Number: 03.233.006
• Device Lot Number: 81P2259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS: TRAUMA