MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS CABLE 4M TO CONSOLE FOR EPD; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.021

Device Problem Device Stops Intermittently (1599)

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

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during an unspecified surgical procedure it was observed that the cable to console device had intermittent operation during cutting.It was not reported if there was a delay in the procedure due to the event.It was reported that an unspecified spare device was available to successfully complete the procedure.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no 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

The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the unit was working intermittently.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: CABLE 4M TO CONSOLE FOR EPD
• 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: 6631204
• MDR Text Key: 77307558
• Report Number: 8030965-2017-12910
• Device Sequence Number: 1
• Product Code: HWE
• 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: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.021
• Device Lot Number: 8237167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2013
• 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