MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE DI SET SCR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 199721000S

Device Problem Material Integrity Problem (2978)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: potential lot numbers reported as 300458, 304310, 297723, 304319.Reporter is a synthes employee.Photo investigation: the device was not returned.A photo-investigation was performed on the received images.The pictures were the explanted devices which appeared not cleaned.The picture revealed an expedium verse dual lock assembly which appeared to have torn thread; hence the complaint is confirmed.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 is confirmed during photo investigation as the thread of the locking key device was observed to be torn; however it is not confirm whether the damage occurred during or before explantation of the device.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventive 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.

Event Description

Device report from the (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, 2 expedium verse screws were damaged.Replacement correction keys were used instead.Procedure was completed successfully with an unknown delay.Patient status is unknown.Upon manufacturer receipt and investigation, it was determined that the device had peeling threads.This report is for a 5.5 exp verse di set screw.This is report 2 of 2 for (b)(4).

• Brand Name: 5.5 EXP VERSE DI SET SCR
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12294948
• MDR Text Key: 265621259
• Report Number: 1526439-2021-01641
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466125
• UDI-Public: (01)10705034466125
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721000S
• Device Catalogue Number: 199721000S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE SCR 5.0X35