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 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One (1) torque wrench handle was returned for evaluation.Visual examination of the torque wrench handle revealed extensive wear, covered with nicks and surface abrasion.Torque testing was performed on this instrument and it was noted that the amount of torque was well above the intended range in all the three settings and was clearly over torquing.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 wrench handle exerting more torque than intended cannot be determined from the sample and the information provided.A potential root cause may be lack of maintenance during its time in use, resulting in the torque wrench exerting slightly more torque than its upper limit.It should be indicated that work instruction (wi-5220 revision l) provides definition of the refurbishment process and minor component replacement process which depuy spine instruments shall follow.Specifically, torque wrenches which have a current 12-month date etched on the handle to indicate the date of the required maintenance.This particular torque wrench does not feature one of these dates etched into it surface.The root cause of excessive torque exerted by torque wrench handles is under investigation and may be tracked through (b)(4).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.

Event Description

Dr.(b)(6) was performing final tightening and noticed that the torque drive was not tightening as it should.The expedium system contacts a second torque drive and as such, dr.(b)(6) completed the surgery with the other torque drive found in the set.No delay was obtained.The screwdriver shaft (torque drive was stripped at the distal tip- but no metal shavings fell into the patient).Since the patient was not affected by this event, no patient information was taken.I have nothing further to add regarding this incident.

• 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: 6175156
• MDR Text Key: 62470870
• Report Number: 1526439-2016-10928
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 277040510
• Device Lot Number: E0605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1