MAUDE Adverse Event Report: DEPUY TRACTION SYSTEM; APPARATUS, TRACTION, NON-POWERED

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

On (b)(6) 2011, stryker medical was notified of a potentially reportable complaint involving a product for which stryker is not the manufacturer.The customer reported a depuy traction system fell off the bed when the traction system cross bar was removed.Please find additional contact information below.N/a.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRACTION SYSTEM
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): DEPUY
• MDR Report Key: 17533907
• MDR Text Key: 321418183
• Report Number: MW5140810
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1