MAUDE Adverse Event Report: DEPUY SYNTHES SPINE TORQUE WRENCH

Catalog Number 277040510

Device Problem Output above Specifications (1432)

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

Event Date 04/20/2017

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 reported products shown below were used for a surgery for lcs (lumber spiral canal stenosis) performed on (b)(6) 2017.Product name: x25 final tightener, item no: 2797-12-600, lot no: gm4291603.Product name: torque wrench, item no: 2770-40-510, lot no: bv676125.The following event occurred during the surgery: the surgeon applied torque with the above product, however, it did not work properly.The surgeon tightened hard, then the tip part of the x25 final tightener got stripped.The surgery was successfully completed by using another driver (unknown item/lot numbers) manually.There was no adverse consequence to the patient.

Manufacturer Narrative

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 above the intended range.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.A trend analysis was conducted.No emerging trends were found requiring further actions.Although not proven, the most probable root cause for the over torquing of the wrench can be attributed to lack of maintenance during its time in use, resulting in the torque wrench exerting slightly more torque.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
• 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: 6613700
• MDR Text Key: 76738165
• Report Number: 1526439-2017-10410
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 277040510
• Device Lot Number: BV673824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2013
• 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