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

Model Number 288306100

Device Problem Calibration Problem (2890)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) reports an event as follows: it was reported that on an unknown date, during an unknown procedure the surgeon could not finally tighten the lateral mass screw using the x15 torque driver.Upon opening a second backup set that had another x15 torque driver, the screw was able to achieve final tightening and torqued out.The two mountaineer oc plates broke in the case as well as the final tightener.It is unknown if fragments were generated and removed.Procedure was completed without surgical delay.Patient outcome was unknown.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).This complaint involves three (3) device.This report is for (1) x15 torque driver.This report is 1 of 3 for pc (b)(4).

Manufacturer Narrative

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.D4, g2, h4: 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.

Manufacturer Narrative

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.H10 additional narrative: investigation summary: visual inspection: the x15 torque driver (part # 288306100, lot # gb107477) was received at us cq.Upon visual inspection, it was observed that the distal tip (drive feature) of the device was twisted.The very distal portion of the tips was rounded, almost worn to the core.Due to the worn condition of the tip, device functionality was compromised.The noted issues were consistent as the end of life indicators for the device.The stripped condition confirms the reported device functional issue.Conclusion: the complaint was confirmed for the received device.After a visual inspection per guidance provided, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot a review of the receiving inspection (ri) for x15 torque driver was conducted identifying that lot number gb107477 was released in a single batch.Batch1: lot was released on 08 jan 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.Corrected data: d9, h3, h6.

• Brand Name: X15 TORQUE DRIVER
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11097383
• MDR Text Key: 239599519
• Report Number: 1526439-2020-02507
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034221441
• UDI-Public: 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2020

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: GB107477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/26/2021; 02/05/2021
• Supplement Dates FDA Received: 01/28/2021; 02/10/2021
• Patient Sequence Number: 1
• Treatment: MNTR OC PLATE SMALL; UNKNOWN SCREWS