MAUDE Adverse Event Report: DEPUY SPINE INC EXP TI POLY SCREW 8MMX80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179712880
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: kwp, mnh, mni, kwq.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.Product was not returned.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 or Problem Description
It was reported that on (b)(6) 2021, during a procedure while placing a left sided s2ai screw, the tip of 5.5 nav driver - shaft t20 sheared off inside the drive recess of the screw.As this was a revision surgery, this screw was already implanted previously and the surgeon was replacing it in a new trajectory.After the driver broke, the screw was successfully removed and a new screw was implanted.The hospital discarded the screw with the broken driver tip.The surgeon¿s complaint is the tip of an expedium 5.5 screwdriver (t20) is too small/weak when inserting larger diameter screws, specifically in revision surgeries such as this when the bone is sclerotic.Procedure was completed successfully.This report is for one (1) exp ti poly screw 8mmx80mm.This is report 2 of 2 for complaint (b)(4).

• Brand Name: EXP TI POLY SCREW 8MMX80MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12816703
• Report Number: 1526439-2021-02424
• Device Sequence Number: 4699252
• Product Code: NKB
• UDI-Device Identifier: 10705034068145
• UDI-Public: (01)10705034068145
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: 179712880
• Device Catalogue Number: 179712880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 NAV DRIVER - SHAFT T20
• Patient Age: 69 YR
• Patient Sex: Unknown
• Patient Weight: 113 KG