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 02/15/2017

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

Two torque drivers stripped.Doctor was tightening, locking screw and the drivers slipped out of the screws and the ends of the shafts are stripped.

Manufacturer Narrative

(b)(4).The returned torque handle featured a minor amount of superficial wear in the form of scuffed/worn anodization and surface markings.The unit was submitted for torque testing.Of the 18 values taken, 8 were above the upper limit considered acceptable by test method tm-100331 rev.11.Generally, the torque values were along the upper limit without a significant amount of variance.The excessive torque may have contributed the damage to the final tighteners¿ hexlobes as the torque wrench would not ratchet off once a certain level of torque had been reached, allowing additional force to be applied to the hexlobes.The torque handle was not submitted for disassembly.Torque handles that have seized or are exerting significantly more torque than intended will feature broken, severely rusted, or severely worn/damaged components.However, this torque handle is exerting slightly more torque than intended.The condition inside the device is not expected to look significantly different than normal, making accurately determining the root cause difficult.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.No emerging trends were found requiring further actions.The root cause of the torque handle exerting excessive torque cannot be positively determined from the sample and information provided.A potential root cause may be rust and damage in combination with the age of the device, resulting in the device exerting more torque than intended.It should be indicated that work instruction (b)(4)revision l was incorporated on may 6th, 2013.This work instruction details the refurbishment process and minor component replacement processes which depuy spine instruments shall follow.Specifically, torque handles which have a current 12-month date etched on the handle to indicate the date of the required maintenance.No date is featured on the handle.Since this handle has been in the field for nearly 5 years, it does not fall within the threshold of depuy¿s refurbishment process per (b)(4) revision l.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 and no systemic trends requiring immediate action have been observed, 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.

• 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: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6435247
• MDR Text Key: 70870461
• Report Number: 1526439-2017-10217
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 277040510
• Device Lot Number: BV664242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2012
• 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
• Patient Age: 65 YR