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

Catalog Number 05.001.010

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 01/18/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturing location was unknown.The serial/lot number was unknown; therefore, the date of manufacture date was unknown.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

This is report 1 of 2 for the same event.It was reported from (b)(6) that during an osteotomy surgical procedure of the mandibular branches, it was observed that the motor on the electric pen drive device started to heat up that the saw blade device also heated up and lost its edge while these device were in use together.According to the report, the increase in temperature on the motor on the electric pen drive caused the saw blade device to also heat up burning both the lips of the patient and the doctor's hand.It was not reported if there was a delay in the surgical procedure.It was not reported if a spare device available for use; however, it was reported that the surgery was completed using a chisel and a hammer.There was patient involvement.It was reported that no medical intervention was required to treat the burn on both the patient and the surgeon, as both were just superficial burn.It was reported; however, that anti-inflammatory and topical ointment were used to treat the burn on the patient's lips.It was not reported if there was a prolonged hospitalization.The patient's status post-surgery was not provided.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Additional information: upon complaint review, it was determined that an additional device (saw attachment) was involved in this event which was inadvertently missed in the initial report.Therefore, this report is 1 of 3 for the same event.This device has been included as a concomitant medical products.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The serial number, date of manufacture and manufacture site name and address were documented as unknown in the initial report.The serial number, date of manufacture and manufacture site name and address have been updated accordingly.The udi has also been updated accordingly.The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device passed all manufacturing specifications.Therefore, the reported condition was not duplicated and confirmed.An assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ELECTRIC PEN DRIVE 60,000 RPM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED
• 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: 7252379
• MDR Text Key: 99369235
• Report Number: 8030965-2018-50839
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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,Followup,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• 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: 03/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2018
• Date Device Manufactured: 02/24/2012
• 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
• Patient Outcome(s): Required Intervention