MAUDE Adverse Event Report: DEPUY SPINE INC TORQUE WRENCH

Catalog Number 277040510

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the torque wrench revealed superficial wear in the form of nicks and scuff marks on its surface.It was noted that the end cap was missing.The torque setting could be changed.The device was mechanically tested and was found to be out of required specification.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The torque wrench has a potential field age of over 14 years.It has been likely subjected to numerous autoclave cycles.Extended use over time can cause the internal lubricant to dry up and the internal components to bind.Although not proven, the most probable root cause for the over torquing of the driver can be attributed to lack of maintenance during its time in use.The root cause of the torque wrench not being able to have its torque setting changed cannot be determined from the sample and the information provided.A potential root cause cannot be determined using the available information, though wear to the internal components of the device, irregular maintenance, and lack of lubrication may be contributing factors.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date, during a routine incoming inspection, it was observed that the torque handle was broken.There was no known patient and procedure involvement.

• Brand Name: TORQUE WRENCH
• Type of Device: WRENCH
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9007609
• MDR Text Key: 158864357
• Report Number: 1526439-2019-52067
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10705034196770
• UDI-Public: 10705034196770
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 277040510
• Device Lot Number: E0305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2005
• 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