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

Catalog Number 05.001.010

Device Problem Device Inoperable (1663)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the device had no power; therefore, the pretest could not be completed.Therefore, the reported condition was confirmed.It was further determined that there was corrosion on the motor and the electrical control unit (ecu).The assignable root cause was determined to be due to improper cleaning, which is user error/misuse/abuse.If additional information should become available a supplemental medwatch will be submitted accordingly.

Event Description

It was reported that during an unspecified veterinary surgical procedure, it was determined that the electric pen drive device was unresponsive.It was not reported if there was a delay in the surgical procedure, or if a spare device was available for use.There was no human patient involvement as this was 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 will be submitted accordingly.

• Brand Name: ELECTRIC PEN DRIVE 60,000 RPM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESSORIES AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7312317
• MDR Text Key: 101571506
• Report Number: 8030965-2018-51395
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819167711
• UDI-Public: (01)7611819167711(11)070115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 05.001.010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2007
• 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