FDA Adverse Event Injury Summary report: N

1220246-2019-00967

MDR report key: 8432384 · Received March 19, 2019

Report

Report Number: 1220246-2019-00967
Event Type: Injury
Date Received: March 19, 2019
Date of Event: June 11, 2018
Report Date: March 19, 2019
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

COMPLAINT CONFIRMED, THE DRIVE WAS FOUND TO BE MISSING THE DISTAL END AND TO BE TWISTED. THE MOST LIKELY CAUSES OF THIS TYPE OF EVENT INCLUDE CONTINUALLY APPLYING TORQUE WHEN THE IMPLANT IS NOT PROPERLY ALIGNED, LEVERAGING, OR TORQUING WHILE LEVERAGING THE DEVICE. IT IS UNKNOWN IF A TORQUE INDICATING ADAPTER WAS USED WITH THIS DEVICE, WHICH IS RECOMMENDED TO PREVENT OVER-TORQUING THAT CAN LEAD TO DRIVER DAMAGE.

Description of Event or Problem · 1

IT WAS REPORTED VIA FACILITY MEDWATCH REPORT ((B)(4)) THAT THE FOLLOWING INCIDENT OCCURRED: "AFTER PLACING A SCREW, THE SCREWDRIVER TIP WAS NOTED TO BE MISSING. UPON EXAMINING PLACED SCREW, THE MISSING TIP WAS VISUALIZED SITTING IN THE SCREW HEAD. THE SCREW SITE WAS INTACT. THE GLENOID COMPONENT WAS THEN IMPLANTED, THEREBY SECURING THIS SCREW WITH THE SCREWDRIVER TIP." THE MEDWATCH REPORT DID NOT CONTAIN A PART/MODEL NUMBER OR A LOT NUMBER. THE DATE SHOWN ON THE MEDWATCH REPORT WAS (B)(6) 2018. ADDITIONAL INFORMATION OBTAINED 2/27/2019: THE ACTUAL DATE OF PROCEDURE WAS (B)(6) 2018. SALES REP HAS OBTAINED THE DEVICE FROM THE FACILITY. PART NUMBER OF THE DRIVER IS AR-9545-T15-02 LOT 8001801. DEVICE BEING RETURNED FOR EVALUATION.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other