MAUDE Adverse Event Report: DEPUY SPINE INC VERSE X25 INSERTER/TIGHTENER; DRIVER

Model Number 299704230

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.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 synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during final tightening the correction screws the x25 inserter tighteners appeared to be burring and not torquing off.There were 10 correction keys to be tightened.The second correction key burred the driver and the inner part of the correction key was also stripped.There were altogether 4 correction keys that were stripped and 4 x25 inserter tighteners burred.The procedure was completed successfully without delay reported.There were no patient consequences.Concomitant device reported: unknown correction key (part# unknown, lot# unknown, quantity 6); unknown torque handle (part# unknown, lot# unknown, quantity unknown); unknown screw (part# unknown, lot# unknown, quantity unknown); unknown rod (part# unknown, lot# unknown, quantity unknown).This complaint involves eight (8) devices.This report is for (1) verse x25 inserter/tightener this is report 05 of 08 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.D10: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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.

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, h4, h6 investigation summary: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided in the attachment(s) ¿x25inserter_correction4.Jpg¿, ¿x25inserter_correction5.Jpg¿, ¿x25inserter_correction6.Jpg¿, ¿c-000726055 engineers assessment 4¿ and ¿c-000726055 engineers assessment 5¿.The image(s) was reviewed, and the complaint condition could be confirmed as the devices appeared to be rounded/stripped.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history a review of the receiving inspection (ri) for verse x25 inserter was conducted identifying that lot number gm4756201 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 30dec2016 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.H11 corrected data: 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: VERSE X25 INSERTER/TIGHTENER
• Type of Device: DRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10321808
• MDR Text Key: 200427444
• Report Number: 1526439-2020-01401
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 10705034467634
• UDI-Public: 10705034467634
• 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,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 299704230
• Device Catalogue Number: 299704230
• Device Lot Number: GM4756201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN HANDLES; UNKNOWN RODS; UNKNOWN SCREWS; VERSE CORRECTION KEY