MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS TORQUE LIMITING ATTACHMENT 0.8NM/QUICK COUPLING; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 511.776

Device Problems Component Falling (1105); Loose or Intermittent Connection (1371); Material Separation (1562); Unraveled Material (1664)

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

Event Date 06/14/2015

Event Type  malfunction  

Event Description

It was reported that during an open reduction internal fixation (orif) surgery to repair a right distal radius fracture, it was observed that the torque limiting device unwound and came apart while loosening a screw and using the device in reverse.According to the report, a washer from the device fell onto the surgical table; however, no pieces of the device fell into the patient.There were no delays in the surgical procedure.It was not reported if a spare device was available for use.The procedure was completed successfully.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The patient outcome was reported as fine.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

There was no contact phone number provided.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.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the coupling shaft was separated from the coupling sleeve and rest of the device.Therefore, the pre-test could not be completed.The reported condition was confirmed.The assignable root cause was determined to be due to user error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TORQUE LIMITING ATTACHMENT 0.8NM/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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4906407
• MDR Text Key: 6831445
• Report Number: 3009450871-2015-12309
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.776
• Device Lot Number: 12915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1