MAUDE Adverse Event Report: DEPUY SPINE INC T20 SCREWDRIVER SHAFT

Model Number 279702050

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that on (b)(6) 2020 during an unknown procedure the surgeon was revising a loose screw (7.5 x 40mm) at l5 on the left and replacing it with an 8.0x40mm pedicle screw.After performing the hardware revision (alternative company), the surgeon determined the l5 screw on the left needed to be backed out a few millimeters to align with the rest of the construct (l2-pelvis.) he used the t20 straight driver to back the screw out.After seating the screw and successfully backing out the implant a half turn, the driver tip striped and broke off inside the screw recess of the pedicle screw.He was not able to retrieve the portion of the driver that sheared off and therefore could not back the screw out adequately to achieve the desired alignment.The surgeon used reduction tools to manipulate the construct and eventually place the rod in within the screw heads.There was a surgical delay of ten (10) minutes.Fragments were generated but the tip of the t20 driver could not be dislodged from the implant.The procedure was successfully completed.Patient status is unknown.Concomitant devices: unknown 8.0x40mm pedicle screw (part# unknown, lot# unknown, quantity unknown); unknown setscrews (part# unknown, lot# unknown, quantity unknown); unknown rod (part# unknown, lot# unknown, quantity unknown).This report is for one (1) t20 screwdriver shaft.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a review of the receiving inspection (ri) for t20 screwdriver shaft was conducted identifying that lot number gm5438502 was released in a single batch.Batch1: lot qty of (b)(4) units were released on (b)(6) 2019 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: T20 SCREWDRIVER SHAFT
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10189128
• MDR Text Key: 196857776
• Report Number: 1526439-2020-01238
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034198453
• UDI-Public: 10705034198453
• 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: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279702050
• Device Catalogue Number: 279702050
• Device Lot Number: GM5438502
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 07/03/2020; 07/21/2020
• Supplement Dates FDA Received: 07/21/2020; 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN LOCKING/SET SCREWS.; UNKNOWN RODS.; UNKNOWN SCREWS.
• Patient Outcome(s): Required Intervention