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

Model Number	511.773
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7186481
• Report Number: 8030965-2018-50277
• Device Sequence Number: 16410658
• Product Code: GEY
• UDI-Device Identifier: 10886982237804
• UDI-Public: (01)10886982237804(11)111004(10)16709
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1