MAUDE Adverse Event Report: STRYKER INSTRUMENTS DRILL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Device Problems Difficult to Insert (1316); Dull, Blunt (2407); Connection Problem (2900)

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

Event Date 07/11/2023

Event Type  Other  

Event Description

Event description: it was reported that during a procedure on (b)(6) 2023, while attempting to put in a locking screw, the torque limiter would not connect to the stryker drill attachment for the surgeon to insert on power.It is unknown if the stryker quick connect was not working properly, or if the torque limiter had issues.Additionally, the surgical tech noticed that the tip of a t-25 screwdriver was rounded off and risking stripping the heads of the screws because it did not seat properly.The screws were hand tightened at the end of the case.The spd manager was advised to replace these products from the sets.Procedure was completed with no surgical delay.There was no patient consequence.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRILL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 17333136
• MDR Text Key: 319503704
• Report Number: MW5119449
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: T-25 SCREWDRIVER.; TORQUE LIMITER.