MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN EXTRACTION INSTRUMENTS

Catalog Number UNK EXTRACTION INSTRUMENTS

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

Patient Problems Injury (2348); Not Applicable (3189)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2018, the removal surgery was performed as planned.The date of primary surgery was unknown.During the removal surgery, the surgeon noticed that some necessary instruments were not found in the expedium instrument box, but he managed to remove the screws by using the hospital-owed screwdriver.At the time of removing the di outer screw, he could not find the screwdriver designed for di outer screw.As a result, he gave up extracting the di outer screw and closed the incision.On (b)(6) 2018, the re-operation for explant was successfully completed and there was no adverse consequence to the patient.

• Brand Name: UNKNOWN EXTRACTION INSTRUMENTS
• Type of Device: UNKNOWN
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7465458
• MDR Text Key: 106703496
• Report Number: 1526439-2018-50414
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK EXTRACTION INSTRUMENTS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/26/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR