MAUDE Adverse Event Report: DEPUY SYNTHES SPINE X15 TORQUE DRIVER; SCREWDRIVER

Catalog Number 288306100

Device Problem Output Problem (3005)

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

Event Date 09/15/2016

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

Dr (b)(6) placed each of the components listed above as part of the posterior hardware construct.Upon torquing the first h2h outer nut, there appeared to be a stripping sound.Upon inspection, it was noted that the inner screw had become dislodged from the tulip of the m/l screw and threads had been torn off the inner screw.This resulted in head splay of the m/l screw which would not allow for placement of an new inner screw.At that point; dr (b)(6) decided to remove all the caps and replace the splayed screw.After he placed the new screw, he chose to forego placing a transconnector final tighten the new construct, after which, he closed the wound which finished the procedure.He asked that we send in the screw, inner nut, outer nut and both torque limit devices for analysis and that we provide him feedback when we determined cause.It was postulated that one or both of the torque drivers may be over torquing and may have led to the incident.

Manufacturer Narrative

One (1) mountaineer x15 torque driver [product code: 2883-06-100] was returned to the chu for evaluation.Visually nothing could be found wrong with device.A functional torque test was then conducted.Torque test results concluded that the device is within the required specifications per test method.No device failures have been identified.Device is functioning as intended.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.A root cause analysis for the x15 torque driver [2883-06-100] is deemed not necessary as no device failures have been identified.Torque test results concluded that the device is within the required specifications.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: X15 TORQUE DRIVER
• Type of Device: SCREWDRIVER
• 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: 6014086
• MDR Text Key: 56982815
• Report Number: 1526439-2016-10753
• Device Sequence Number: 1
• Product Code: HXX
• 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: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 288306100
• Device Lot Number: GB72799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 78 YR