MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN AWLS; EXPEDIUM® VERSE SPINE SYSTEM

Catalog Number UNK AWLS

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).510k: this report is for an unknown awe/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that dr (b)(6) was performing a l4-5 right sided navigated posterior instrumented fusion on the patient at (b)(6) hospital.When using the modified pedicle awl with sleeve, the tip was damaged.The nurse informed the dr.That she was unsure if the tip had come off in the patient as she did could not find it.The dr.Was not concerned with this and on the x-ray taken at the completion of the procedure, no tip or fragment was seen.No delay was experienced.The awl has been tagged for repair and is currently at the hospital.The surgeon completed the procedure, the damaged awl was not used again.Patient status/ outcome / consequences are unknown.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: UNKNOWN AWLS
• Type of Device: EXPEDIUM® VERSE SPINE 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: 9417535
• MDR Text Key: 185304759
• Report Number: 1526439-2019-52587
• Device Sequence Number: 1
• Product Code: HWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AWLS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1