MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CUSTOM EXP MONO SCREWDRIVER

Catalog Number 697327779

Device Problems Break (1069); Torn Material (3024)

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

Event Date 10/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Sample not returned for evaluation.

Event Description

As surgeon was repositioning a 5x35 ml screw, the driver thread sheared off.The sheared piece of metal was removed from patient and the driver is no longer useable.Replaced with same like product to proceed with the procedure.Patient initials: (b)(6).Age: (b)(6).Gender: male.Patient was fine post-surgery.5 minutes delay in surgery.No adverse event to patient.Discarded = no return to manufacturer unless local engineering assessment indicates return is required.This case is not being reported by the customer, but jjm employee.All available information has been provided as part of this report.No further information will be forthcoming.

• Brand Name: CUSTOM EXP MONO SCREWDRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5204769
• MDR Text Key: 30531196
• Report Number: 1526439-2015-10905
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 697327779
• Device Lot Number: G0508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR