MAUDE Adverse Event Report: DEPUY SPINE INC POLY SCREW DRIVER SHFT X20; SCREWDRIVER

Model Number 2020-33-400

Device Problems Mechanical Problem (1384); Device Slipped (1584); Mechanical Jam (2983)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in norway as follows: it was reported that during a procedure on (b)(6) 2023, when the screw was long, the retention sleeve stopped screwing together clockwise with the screwdriver x25 and then the screw was unscrewed from the screwdriver.This happened approximately at a depth of 15-20 mm of the length of the screw was into the patient.It got too much of resistance that the retention sleeve stopped and did not move as a unit with the x25 screwdriver.It is unknown if it was the screw that stopped moving in the patient or the tension sleeve.It was threaded first, before inserting the screw.It was done as instructed in the picture by not being close to areas marked x and only within the red rounding.Surgeon then had to screw (no.1 clockwise to tightened the screw on again) the retention sleeve back on, but it stopped again after 1-3 revolutions.So they screwed in the last mm by turning on the retention sleeve and not the handle.This does not apply to normal screw insertion without a navigation sleeve.The screws were on correctly, and they have been screwed hard on before inserting, making sure they are secured.There was 20-30 minutes of surgical delay.The procedure was completed successfully by using similar products.This report is for one (1) poly screw driver shft x20.This is report 1 of 1 for complaint (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.Device product code: olo.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.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.

• Brand Name: POLY SCREW DRIVER SHFT X20
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 16463621
• MDR Text Key: 310795773
• Report Number: 1526439-2023-00398
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034530994
• UDI-Public: (01)10705034530994
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K191943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 2020-33-400
• Device Catalogue Number: 202033400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AO HANDLE MEDIUM W RATCHET.; C1 ALIGNMENT AND NAV SLEEVE.; POLY SCREW DRIVER RETEN SLEEVE.