MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT, LONG, FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.224

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Manufacturer Narrative

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 further determined that the bearings were rusted-in and did not run smoothly.It was further determined that the needle bearing was rusted and the needles were scattered in side of the housing of the attachment device.It was observed that the adjuster fork was rusted on the surface and the coating was partly worn.It was further determined that the it was observed that the shaft coupling had a light rust film on the shaft and the eccentric shaft had pitting corrosion and a hair-line crack on the base of the shaft.It was further determined that the device failed pretest for check of free movement, check the oscillation frequency min 9900 to 12100osc/min and check the saw performance.It was further determined that all of the steps of the pre-repair diagnostic could not be performed because the attachment moved heavily.It was determined that the mechanics was dirty, oily and corroded.It was further determined that the mechanics seized, jammed and was moving heavy.It was observed that the bearing was not functioning and was defective.The assignable root cause was determined to be due to normal wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

This is report 8 of 10 for the same event: it was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that seven sagittal saw attachment devices stopped working less than one minute after starting.It was not reported if there were any delays in the surgical procedure.There was patient involvement reported.It was not reported if there were any 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.

• Brand Name: SAGITTAL SAW ATTACHMENT, LONG, FOR TRS
• 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
• Manufacturer (Section G): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7302708
• MDR Text Key: 101574707
• Report Number: 8030965-2018-51365
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819377929
• UDI-Public: (01)07611819377929(11)160203
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.224
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Date Manufacturer Received: 02/02/2018
• Date Device Manufactured: 02/03/2016
• 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