MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXTENDED TAB POLYAXIAL DRIVER, 10MM; DRIVER, PROSTHESIS

Catalog Number 286760010

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A 279712600: tip of driver shaft deformed properly using is not possible.A 286760010: thread of shaft deformed properly using is not possible.A 286735400: thread of shaft deformed properly using is not possible.

Manufacturer Narrative

The investigation has been completed; the product was returned to the chu for evaluation.Visual inspection could not confirm the reported complaint.Visual examination of the poly-driver, 10mm revealed some signs of operative usage but no significant damage and is functioning as intended.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXTENDED TAB POLYAXIAL DRIVER, 10MM
• Type of Device: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 5759930
• MDR Text Key: 48506829
• Report Number: 1526439-2016-10464
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 286760010
• Device Lot Number: MI28295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2013
• 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