MAUDE Adverse Event Report: DEPUY SPINE INC DRIVER SHAFT FOR SI SCREWS; SCREWDRIVERS

Model Number	279712150
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.(b)(4).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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for an xlif (extreme lateral interbody fusion) at l4/5.When surgeon removing the screws at s., the screwhead came off.Surgeon left the shaft in the patient.All fragments were left in the patient.The surgery was completed with 30 minutes delay.The patient is not scheduled to undergo another procedure.The patient outcome was unknown.This complaint involves four (4) devices.This report is for (1) depth gauge for small screws.This report is 1 of 1 for (b)(4).

• Brand Name: DRIVER SHAFT FOR SI SCREWS
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10970055
• Report Number: 1526439-2020-02371
• Device Sequence Number: 871481
• Product Code: HXX
• UDI-Device Identifier: 10705034198835
• UDI-Public: 10705034198835
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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
• Operator of Device: Health Professional
• Device Model Number: 279712150
• Device Catalogue Number: 279712150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention