MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC TORQUE LMTG ATCH 1.5NM, QUICK COUPLING; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number 511.773

Device Problem Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the device failed pretest for torque check (step #70); specification = minute 1.35 to 1.65 nm, actual reading was minute 1.278 nm and max.1.482 nm (failed the torque limiting tolerance range specification).Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a suplemental medwatch will be submitted accordingly.

Event Description

It was reported that during a tibial plateau levelling osteotomy surgical procedure on an unspecified animal, it was observed that the torque limiting device was no longer making a clicking noise and had reached its upper limit.There was a five minute delay to the surgical procedure.A spare device was not available for use.The procedure was completed with no further issues.There was no human patient involvement as this was a veterinary surgical procedure.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.

• Brand Name: TORQUE LMTG ATCH 1.5NM, QUICK COUPLING
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA ; 6107195000
• MDR Report Key: 7186481
• MDR Text Key: 97744925
• Report Number: 8030965-2018-50277
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 10886982237804
• UDI-Public: (01)10886982237804(11)111004(10)16709
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 511.773
• Device Catalogue Number: 511.773
• Device Lot Number: 16709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Date Manufacturer Received: 12/14/2017
• Date Device Manufactured: 10/04/2011
• 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