MAUDE Adverse Event Report: DEPUY SPINE INC VERSE POLY DRIVER, HANDLE; MISC ORTHO SURGICAL INSTR

Model Number 299704152

Device Problem Device-Device Incompatibility (2919)

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

Event Date 12/03/2020

Event Type  malfunction  

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 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 (b)(6) 2020 the patient underwent for a degenerative surgery.During the surgery, both of the screwdrivers shaft was disengaged with the screw.The surgery was completed without any other issue.The patient outcome was unknown.This complaint involves five (5) devices.This report is for (1) verse poly driver, handle.This report is 4 of 5 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.H10 additional narrative: d9: device received.D11: additional concomitant device reported.H3, h4, h6: device history lot a review of the receiving inspection (ri) for verse poly driver, handle was conducted identifying that lot number pu124765 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 08 jun 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 batch null, 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.Investigation summary background.Shaft for screwdriver disengage meaning screw was not fixed well with both screwdriver so he used another one and the case went well with no issues.Source: national guard surgery: degenerative.This complaint involves five (5) devices.Investigation flow: device interaction/functional visual inspection: visual inspection performed at customer quality (cq) showed no issues to the instrument, no signs of damage.A device failure was not identified.Functional test functional test was performed with the returned screwdriver and no issues were observed; additionally the handle does not interact directly with the screw.Dimensional inspection: a dimensional inspection was performed as no issues were noted on the instrument.Document/specification review: the following drawings were reviewed: - expedium verse poly driver driver body: (b)(6).Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: no definitive root cause was able to be determined as the complaint is unconfirmed.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed 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.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 POLY DRIVER, HANDLE
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11101785
• MDR Text Key: 249394677
• Report Number: 1526439-2020-02523
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10705034477138
• UDI-Public: 10705034477138
• 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: 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 299704152
• Device Catalogue Number: 299704152
• Device Lot Number: PU124765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Date Manufacturer Received: 02/02/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS; UNKNOWN SCREWS; VERSE POLY DRIVER, HANDLE; VERSE POLY DRIVER, HANDLE; VERSE POLY DRIVER, HANDLE; VERSE POLY DRIVER, SHAFT; VERSE POLY DRIVER, SHAFT; VERSE POLY DRIVER, SHAFT; VERSE POLY DRIVER, SHAFT