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 Unintended System Motion (1430)

Patient Problem Not Applicable (3189)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.The reporter¿s complete facility address was not provided.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.Udi: (b)(4).

Event Description

It was reported from (b)(6) that during an unspecified veterinary surgical procedure, it was observed that the hand switch part of the electric pen drive device moved without touching it.The reporter indicated that they were unable to determine whether the device caused the issue.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was no human patient involvement as the device was used in a veterinary procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device history record review: a device history review was performed and no non-conformances were detected related to the reported condition.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device and determined that the device passed all inspection criteria during the diagnostic assessment.However, during repair, the device was disassembled, and the internal parts were inspected.It was found that the contacts on the electronic control unit (ecu) were covered in verdigris (corrosion), which was the result of a liquid that had started to corrode the contacts.It was further determined that the motor showed signs of liquid residues.It was noted that unintended motion was not confirmed, however it was determined that the corrosion could lead to this failure if the device is used for a long period of time.Therefore, the reported condition was confirmed.It was determined that due to the age of the device and the fact that rest of the parts (seals, bearing and mechanical parts) did not show any signs of improper handling or reprocessing, premature wear was the most probable cause for the found defect.The assignable root cause was determined to be due to component failure from normal wear.If additional information should become available, a supplemental medwatch report 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: 10442157
• MDR Text Key: 204039600
• Report Number: 8030965-2020-05930
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819167711
• UDI-Public: 07611819167711
• 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
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• 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: 08/31/2020
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1