MAUDE Adverse Event Report: DEPUY SPINE INC X15 TORQUE DRIVER; SCREWDRIVERS

Model Number 288306100

Device Problem Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from australia reports an event as follows: it was reported that on an (b)(6) 2019 that both of the x15 torque driver 288306100 tips were damaged on the mountaineer set used for a c4-c7 posterior cervical fusion.The first driver kept slipping due to the damaged tip, the second driver did torque off but the tip is damaged as well.The procedure was completed successfully and there was no adverse outcome for the patient.Concomitant device: unknown setscrews (part#: unknown, lot#: unknown, quantity 1).This report is for one x15 torque driver.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation was performed by engineering technician: dept:- engineering services.Both tightening ends of the 288306100 x15 torque drivers are worn and burred.The noted damage is consistent with wear and tear over the device's life-cycle.A manufacturing related potential cause was not suspected, therefore, no manufacturing record evaluation is required.The overall complaint was confirmed as the stripped condition is consistent with an end of life indicator for the device.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential signals will be conducted through complaint trending and other post market safety surveillance activities.

• Brand Name: X15 TORQUE DRIVER
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9530066
• MDR Text Key: 175727999
• Report Number: 1526439-2019-52806
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034221441
• UDI-Public: (01)10705034221441
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 288306100
• Device Catalogue Number: 288306100
• Device Lot Number: GB1010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/12/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN LOCKING/SET SCREWS