MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC RECON SAGITTAL SAW WITH KEY FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 05.001.240

Device Problems Unintended System Motion (1430); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (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

It was reported from (b)(6) that during a total knee surgical procedure, it was observed that the recon sagittal saw device was running without being activated and soon lost power entirely and would not start functioning again.It was unknown if there were any delays to the surgical procedure or if a spare device available for use.There was patient involvement.There were no 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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device was not working, trigger magnet support was broken, there was an unknown liquid substance and the components were contaminated with grease and some components were worn.The device also failed pretest for check for leakage and check for function for all modes.Therefore, the reported condition was confirmed.The assignable root cause was traced to component failure due to faulty parts.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: RECON SAGITTAL SAW WITH KEY FOR TRS
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9166225
• MDR Text Key: 191596301
• Report Number: 8030965-2019-69060
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819462588
• UDI-Public: 7611819462588
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1