MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC RECIPROCATING SAW ATCH FOR PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.040

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant devices: saw blade device, electric pen drive device, foot pedal device.The manufacturing location was unknown.The device manufacture date was unknown.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

It was reported from (b)(6) that during a genioplasty surgical procedure, it was observed that while using the reciprocator saw device by hand and then switching to the foot pedal, the speed settings were set to 75% then dropped to 50% within five minutes.The device then began to overheat and the saw device began stopping and proceeding on its own accord.According to the reporter, the user waited for the device to cool down as per the troubleshooting guide, however the device showed no signs of working.During this time, irrigating was being used.It was reported that the reciprocator saw device was being used with an electrical pen drive device and saw blade devices.It was reported that there was a forty minute delay to the surgical procedure.It was unknown if a spare device was available for use.There was patient involvement.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 will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the coupling was worn out and did not work correctly, the bearings did not run smoothly and the front part showed a change in color due to overheating.The device also failed pretests for check version of lilting rod w/connecting rod, check the saw blade coupling and check of free moving.Therefore, the reported condition was confirmed.The assignable root cause was traced to component failure due to normal wear.A device history review was performed, and no non-conformances were detected related to the reported condition.H4: the device manufacture date was reported as unknown in the initial medwatch report.This has been updated to jul 18, 2005.G1-2: the manufacturer location was documented as unknown in the initial report.The location has been updated to oberdorf.Contact office name/address has been updated accordingly to reflect the correct manufacturing facility.Corrected data: d4: the device lot number was reported as 1338086 in the initial medwatch report.This information has been updated to 1368086.Udi - (b)(4).

• Brand Name: RECIPROCATING SAW ATCH FOR PEN DRIVE
• 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
• MDR Report Key: 9823767
• MDR Text Key: 192022374
• Report Number: 8030965-2020-01747
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819167902
• UDI-Public: 07611819167902
• Combination Product (y/n): N
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.040
• Device Lot Number: 1368086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1