MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS HIGH SPEED ELEC G1 HANDPIECE AIR COOLED; MOTOR, DRILL, ELECTRIC - HANDPIECE

Catalog Number EG1A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

Additional narrative: serial number unknown; (b)(4).The serial number was unknown.Therefore, device manufacture date is unknown as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 1 of 2 for the same event: it was reported from (b)(6) that during a craniotomy for tumor resection surgical procedure, it was discovered that the underlying dura was compromised when the drilling stopped.According to the report, the motor device, compact speed reducer device and a disposable perforator device were being used together to perform the craniotomy.It was reported that the user attempted to access another area on the cranium but it was discovered that the underlying dura at that site was also compromised.It was reported that the procedure was being performed by a neurosurgery resident under the supervision of a surgeon.It was reported that the event occurred during use on an elderly female patient for a treatment.It was unknown which or if any of the devices malfunctioned and caused the dural injury.It was unknown if the user of the device made an error.It was unknown if the patient had dural adhesions prior to craniotomy.It was unknown if there were any delays in the surgical procedure or if spare devices were available for use.It was reported that the same devices were used throughout the surgery.It was unknown if there was any medical intervention or prolonged hospitalization as a result of this event.It was unknown if the procedure was completed successfully.The patient's condition post-surgery was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: HIGH SPEED ELEC G1 HANDPIECE AIR COOLED
• Type of Device: MOTOR, DRILL, ELECTRIC - HANDPIECE
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 6410758
• MDR Text Key: 70120851
• Report Number: 1045834-2017-10658
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EG1A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: COMPACT SPEED REDUCER DEVICE; DISPOSABLE PERFORATOR DEVICE
• Patient Outcome(s): Required Intervention