MAUDE Adverse Event Report: STRYKER TRAUMA SA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 2351-4218S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/17/2022

Event Type  malfunction  

Event Description

During procedure when drilling for screw placement, the stryker 4.2 x 185mm freehand drill, the tip of the drill bit, 10 mm, broke inside the patient's femur.It is hard to determine what may have caused this, hard bone, pushing too hard on the drill bit, etc.Doctor unable to remove.

• Brand Name: NA
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA SA; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 15672620
• MDR Text Key: 302423535
• Report Number: 15672620
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2351-4218S
• Device Catalogue Number: 2351-4218S
• Device Lot Number: KU151748
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6205 DA
• Patient Sex: Male
• Patient Race: Black Or African American