MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW; NAIL, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - nail head elements: multiloc humeral screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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, patient underwent revision surgery due to nonunion.The patient had sustained an open humerus fracture that was temporarily put in an external fixator and eventually nailed with multiloc nail.The screws through the nail had quite a bit of bony overgrowth which made them difficult to remove.They are all successfully removed intact, and the nail was removed successfully.The nonunion fracture was then fixated with an extra-articular distal humerus plate along with a 3.5 lcp plate.This report is for one (1) unk - nail head elements: multiloc humeral screw.This is report 2 of 6 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.H6: a manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.Photo investigation: the device was not returned.A photo-investigation was performed on the x-ray.Since the x-ray shows the plate with all 5 screws still intact, the complaint condition cannot be confirmed.Additionally, the root cause of the issue cannot be determined based on the available information.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 cannot 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 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: UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11849176
• MDR Text Key: 251451558
• Report Number: 2939274-2021-02430
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• Patient Sequence Number: 1
• Treatment: 8.5 TI MULTILOC HUM NL LFT/CANN/300-S; UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; 8.5 TI MULTILOC HUM NL LFT/CANN/300-S; UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Weight: 100