MAUDE Adverse Event Report: DEPUY SYNTHES SPINE TORQUE LIMITING HANDLE; PROBE

Catalog Number 299704255

Device Problem Output below Specifications (3004)

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

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

(b)(6) reported verse complaint.Waiting for complaint form (b)(6) 2016 manos.On (b)(6) 2016 during a t10 pelvis with verse instruments and implants the surgeon feels like screw head moved when distracting off of it after it had been torqued.This occurred on three levels where the surgeon and pa visibly said the screw head just torqued moved during distraction.The surgeon then took an intermediate x25 driver to those set screws and screws already torqued and was able to tighten down the set screw still into the head even after it had torqued out.End result surgeon feels like the torque is torqueing out before completely engaged and seated.All 18 set screws were hand tightened for the case as tight as surgeon could but not torqued surgeon would like a followup call from engineer to discuss, please contact manos.

Manufacturer Narrative

Udi: (b)(4).One (1) verse 3in1 driver torque wrench [product code: 2997-04-320, lot no: gb64808] was returned to the complaints handling unit (chu) for evaluation.Visually nothing could be found wrong with the torque handle wrench.Device was then sent to the npd lab for torque testing.Testing found that the device was functioning as intended per test method.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 for the torque wrench is deemed not necessary.Testing results found that the device was functioning as intended per test method specifications.As such, no device failures have been identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TORQUE LIMITING HANDLE
• Type of Device: PROBE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5441619
• MDR Text Key: 38343690
• Report Number: 1526439-2016-10136
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 299704255
• Device Lot Number: GB64808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• 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