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

Catalog Number 05.001.002

Device Problems Device Emits Odor (1425); Device Inoperable (1663); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

The serial number was unknown.Therefore, device manufacture date is unknown.The manufacturing location was unknown.(b)(6).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

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that an odor generated from the console device while its motor was generating a rotation sound.It was further reported that the power lamp was not illuminated on the device.According to the report, the event occurred when the surgeon turned on the device.As a result, the surgeon stopped the surgery; and ordered an alternative console device and a power cable device.It was reported that while waiting for the alternative devices, the patient wore off general anesthesia.It was reported that once the alternative devices were received, the patient was given a general anesthesia again; and the surgery was completed without any other issues.There was a delay to the surgical procedure; however, the duration of the delay was not specified.There was patient involvement.It was not reported if there was prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Device history record review: a device history review was performed and no non-conformances were detected related to the reported condition.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.It was observed that the console device failed during pre-repair diagnostic assessment.Subsequently, testing could not be performed.It was observed that the console did not start up as the power supply was without function and was damaged.The assignable root cause was determined to be due to wear from normal use and servicing.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.Additional narrative, correction: the device was further investigated, and it was determined that the power on test failed and certain tests could not be performed because the console device did not power on.During the investigation, it was observed that the power supply inside of the console was defective.It was further determined that the power supply did not show any failures that could have been related to a manufacturing or design issue.Therefore, the assignable root cause was corrected from normal wear to premature wear from use and servicing.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 manufacturer location was unknown in the initial report.The location has been updated to waldenburg.The contact office name/address has been updated accordingly to reflect the corrected manufacturing facility.Device manufacture date: the device manufacture date was unknown in the initial report.The device manufacture date has been updated as 7/11/2014.Serial number: the serial number was unknown in the initial report.The serial number has been updated as (b)(4).The udi has been updated accordingly.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BASIC CONSOLE FOR ELECTRIC PEN DRIVE
• 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: 7273922
• MDR Text Key: 100238386
• Report Number: 8030965-2018-51144
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819167704
• UDI-Public: (01)07611819167704
• Combination Product (y/n): N
• PMA/PMN Number: K093361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.002
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention