MAUDE Adverse Event Report: DEPUY SPINE INC MOD T20 DRIVER SHORT; DRIVER, PROSTHESIS

Model Number	698337505
Medical Device Problem Codes	Entrapment of Device (1212); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2020
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 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 on (b)(6) 2020, the patient underwent for a surgery.During the surgery, when screwing down screw the tip of t20 short driver broke off and stuck in head of screw.Also, torque driver burred at tip.Unable remove tip of screw.The surgery completed successfully without delay.There were no patient consequences.This complaint involves three (3) devices.This report is for (1) mod t20 driver short.This report is 2 of 3 for (b)(4).

• Brand Name: MOD T20 DRIVER SHORT
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11102825
• Report Number: 1526439-2020-02526
• Device Sequence Number: 3768010
• Product Code: HWR
• UDI-Device Identifier: 10705034377261
• UDI-Public: 10705034377261
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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): 12/04/2020

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: 698337505
• Device Catalogue Number: 698337505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/31/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS; X25 FINAL TIGHTENER
• Outcome Attributed to Adverse Event: Required Intervention