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 Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

Event Description

This is event 1 of 2 of the same event.It was reported that during an unspecified surgical procedure, it was observed that the electric pen drive device and reciprocating saw attachment did not engage nor lock in the cutter devices while in use together.There were no delays in the surgical procedure as an identical spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown; however, it was noted that the event occurred on (b)(6) 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation and it was determined that the reported condition was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was determined that the pick-up coupling, the electric control unit (ecu) and motor were corroded; and the device failed cable coupling testing due to normal wear from use and servicing over time.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
• 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: 7439277
• MDR Text Key: 105774890
• Report Number: 8030965-2018-53176
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819167711
• UDI-Public: (01)7611819167711(11)130207
• 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,Followup
• Report Date: 03/26/2018

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: Health Professional
• Device Catalogue Number: 05.001.010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 06/08/2018
• Supplement Dates FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1