MAUDE Adverse Event Report: SYNTHES MONUMENT SAW BLADE 90MM X 12.5MM 1.19MM CUT THICKNESS; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number 05.003.104

Device Problems Mechanical Problem (1384); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

Event Description

This is report 2 of 2 for the same event.It was reported that during a total knee surgical procedure it was observed that the battery oscillator device would not release the saw blade device as the blade remained stuck inside the oscillator device.It was reported that there was no delay in the procedure due to the event.It was not reported if a spare device was available for use.It was reported that the procedure was successfully completed.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The saw balde 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 with this device.It was determined that the cause of the saw blade becoming stuck was due to the battery oscillator device used in the procedure.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: SAW BLADE 90MM X 12.5MM 1.19MM CUT THICKNESS
• Type of Device: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6560678
• MDR Text Key: 75151198
• Report Number: 1719045-2017-10452
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 05.003.104
• Device Lot Number: 658821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1