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

Catalog Number 05.001.010

Device Problems Loose or Intermittent Connection (1371); Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition of the intermittent function could not be confirmed.Therefore, an assignable root cause was not determined.However, the loose component reported was confirmed.It was determined that the device was found to have a loose component; therefore, the device could not be completely tested.It was determined that the release sleeve had come off.It was further determined that the device failed the cable coupling test and the switch sleeve would not rotate with the gauge inserted.It was further determined that the electric motor/electronic control unit assembly had aged (non-failure).The assignable root cause of the loose component was determined to be due to wear from normal use over time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during a prodisc nova surgical procedure, it was observed that the electric pen drive device was functioning intermittently.According to the reporter, when the surgeon went to create the keel cut with the device, they noticed the device was having difficulty.It was reported that the surgeon stopped using the device and examined it.They noticed that a section of the distal end of the device was loose.It was not reported if there were any delays in the surgical procedure.A spare device was available to complete the surgery.There was patient involvement reported.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.

• 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 POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6639917
• MDR Text Key: 77532425
• Report Number: 8030965-2017-12988
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.010
• Device Lot Number: 2710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2009
• 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