MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC CABLE 3M TO CONSOLE FOR EPD; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Model Number	05.001.025
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter's complete address were not provided.Reporter's phone number: (b)(6).The actual device was returned for evaluation.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once investigation has been completed, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
This is event 3 of 6 of the same event.It was reported from (b)(6) that during an unspecified maxillofacial surgical procedure, it was observed that the electric pen drive (epd) device was connected by cable device to the console device prior to use.According to the reporter, the pen drive device became so hot that it burned a hole through his sterile robe and scrubs.The surgeon and patient were not hurt in any way, however, the surgeon did have to get scrubbed again.It was also observed that the reciprocating saw attachment device was not working properly, seeming to get stuck when using a rasp device and reciprocating saw blade device.The company representative tried to run the epd set but could not replicate the problem.The user tried running the attachment device without any cutter while connected to the pen drive and it continued to spin even though the device was completely disconnected.It continued spinning and making a whirring sound for at least thirty seconds.There were no delays in the surgical procedure as an identical spare device was available for use.There was patient involvement.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device passed all operational specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: CABLE 3M TO CONSOLE FOR EPD
• Common Device Name: 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: 7125922
• Report Number: 8030965-2017-50755
• Device Sequence Number: 19135121
• Product Code: HWE
• UDI-Device Identifier: 10886982128362
• UDI-Public: (01)10886982128362(11)160218(10)9832517
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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
• Operator of Device: Health Professional
• Device Model Number: 05.001.025
• Device Catalogue Number: 05.001.025
• Device Lot Number: 9832517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1