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 Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

The reporter¿s phone number was not provided.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during pre-surgery, it was observed that the blade device did not remain in the seat of the recon sagittal saw device.It was not reported if there were any delays in the surgical procedure or if a spare device was available.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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 device availability was inadvertently documented as 3/22/2018 in the initial report.The date returned to manufacturer was corrected to 6/14/2018.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.It was determined that the thread saw coupling was stripped and defective.It was further determined that the clamping screw was defective.It was further determined that the device failed pretest for check response of on/off trigger, check function of all modes and check the saw blade coupling.The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report 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: 7406473
• MDR Text Key: 104668972
• Report Number: 8030965-2018-52863
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819462588
• UDI-Public: (01)7611819462588(11)131022
• 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: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.240
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1