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

Catalog Number 511.773

Device Problems Calibration Error (1078); Power Problem (3010)

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

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during a left tibia distal fracture surgery, it was observed that the torque limiter device, when applying a 3.5mm medial distal tibia plate into the 3.5mm locking screws, was not calibrated correctly and was under-powering the screws.It was further reported that the doctor continued to use the same torque limiter device to finish the procedure.It was also reported that the doctor, once finished, went back to each of the locking screws and attempted to tighten them with a hand screw driver device and was still able to get two to three turns out of each screw.It was not reported whether there were any delays in the surgical procedure.It was reported that a spare device was available for use.It was reported that the procedure was successfully completed.There was patient involvement reported.The patient status was reported as stable.There were no injuries, 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

Additional narrative: the manufacturer location was documented as unknown in the initial report.The location has been updated to waldenburg.Contact office name/address has been updated accordingly to reflect the correct manufacturing facility.The device manufacture date was documented as unknown in the initial report.It has been updated to oct.31, 2008.Lot number was reported as unknown in the initial report has been updated to 11833.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TORQUE LMTG ATCH 1.5NM, QUICK COUPLING
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6113124
• MDR Text Key: 60847363
• Report Number: 2520274-2016-15437
• Device Sequence Number: 1
• Product Code: GEY
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.773
• Device Lot Number: 11833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2008
• 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