MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC ELECTRIC PEN DRIVE 60,000 RPM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.010

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Unspecified Infection (1930); Pain (1994)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Concomitant device: plug device, drill / burr attachment device, drill attachment j-latch coupling device, and cable device, therapy date: (b)(6) 2019.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.Reference manufacturer report number: 8030965-2019-68139 for report 1 of 4, and 8030965-2019-68350 for report 4 of 4 of the same event.

Event Description

This is report 3 of 4 for the same event: it was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the ¿plug¿ was stuck in the handpiece device while being used together with the drill attachment j-latch coupling device, drill / burr attachment device, and cable device.According to the reporter, the issue was observed several times during pre-surgery.It was further reported that the patient had to be hospitalized longer due to a burnt lip (infection and pain) which resulted in swelling and post-surgical pain.There was a fifteen-minute delay to the surgical procedure.A spare device was available for use.There was patient involvement reported.There was medical intervention and prolonged hospitalization associated with this event.The exact date of the event was unknown.However, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Event: during a subsequent follow-up with the reporter, additional information was obtained.The reporter confirmed that there was no allegation of malfunction against the cable device (05.001.021).Therefore, the cable device (manufacturer report number: 8030965-2019-68350) has been excluded from this event.Furthermore, the event numbering represented in the initial report has been updated from ¿report 3 of 4 for the same event¿ to ¿report 3 of 3 for the same event¿.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The actual device was returned for evaluation.Quality engineering evaluated the device and determined that the reported condition could not be confirmed.However, during repair it was determined that the device was not working due to a broken motor and electrical control unit (ecu) which was caused by overloading.The device also failed pretests for check function and direction of rotation, check function with test hand switch, check function with foot pedal and check with test bench and record results.The assignable root cause was determined to be due to improper handling.A review of the service history record indicates that the device had been returned previously for a non related malfunction.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: ELECTRIC PEN DRIVE 60,000 RPM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9078428
• MDR Text Key: 160934894
• Report Number: 8030965-2019-68161
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819167711
• UDI-Public: 7611819167711
• Combination Product (y/n): N
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention