MAUDE Adverse Event Report: DEPUY SYNTHES SPINE TORQUE WRENCH HANDLE

Catalog Number 277040510

Device Problem Output above Specifications (1432)

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

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

(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

The torque does not work.Per rep, when they turn the handle the torque function does not work.It does not click over when reaching the 10n.

Manufacturer Narrative

The torque handle wrench was returned for evaluation.Functional testing was conducted and the wrench was out of specification.A review of the device history record found no issues that could have caused or contributed the wrench to be out of specification.Trending was completed and no immediate product action is required.An internal data review has been opened to review design control documentation and similar failures will be monitored as a part of post market surveillance activities.A possible root cause for the wrench being out of specification is a lack of lubrication.This complaint will be closed with no further action as there were no issues identified in the manufacturing and an internal data review has been opened to further review these failures.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TORQUE WRENCH HANDLE
• Type of Device: WRENCH
• 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: 5225895
• MDR Text Key: 31260526
• Report Number: 1526439-2015-10938
• Device Sequence Number: 1
• Product Code: HXC
• 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: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 277040510
• Device Lot Number: E1206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2006
• 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