MAUDE Adverse Event Report: DEPUY SYNTHES SPINE TORQUE WRENCH HANDLE

Catalog Number 277040510

Device Problem Output above Specifications (1432)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2017

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

The torque is not activating.

Manufacturer Narrative

(b)(4).One (1) torque wrench handles was returned for evaluation.Visual examination of the torque wrench handle revealed extensive wear, surface anodization was heavily faded and covered with nicks and surface abrasion.Torque testing was performed on this instrument and it was noted that the amount of torque was consistently below the intended range in 80 in-lbs.Settings and was clearly under torquing.The torque selector knob couldn¿t be changed to other settings, as knob was stuck.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 torque wrench has a potential field age of over 3.5 years.It has been extensively used based upon its worn appearance, and was likely subject to numerous auto clave cycles.Oxidation can occur within the instrument's internal mechanism because of repeat auto clave cycles.Failure to lubricate the instrument can lead to a possible scenario of pin starting to gouge the inner surface of the torque body which overtime result in binding and difficulty in turning the knob.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 under torquing of the wrench can be attributed to lack of maintenance during its time in use, resulting in the torque wrench exerting slightly less torque than its lower limit.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: 6431238
• MDR Text Key: 70792428
• Report Number: 1526439-2017-10216
• 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: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 277040510
• Device Lot Number: BV671538
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2012
• 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