MAUDE Adverse Event Report: STRYKER STRYKER SYSTEM 6 DRILL; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Device Problems Entrapment of Device (1212); Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

It was reported that during a trochanteric fixation nail surgery on (b)(6) 2014 a stryker system 6 drill was used with synthes devices.The tip of the synthes reamer head broke into four pieces in the femoral canal, all pieces were retrieved.The tip of the synthes flexible shaft did not break but wrapped around the reaming rod.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STRYKER SYSTEM 6 DRILL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER
• MDR Report Key: 17529639
• MDR Text Key: 321190839
• Report Number: MW5136564
• Device Sequence Number: 1
• Product Code: KIJ
• 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: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1