MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS SUPER SUCKER SHORT, X50 BULK PACKED; INSTRUMENT, SURGICAL, DISPOSABLE - SUCTION TIP

Catalog Number 63-SS2-1

Device Problem Break (1069)

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

Event Date 02/01/2014

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.A visual assessment was performed which confirmed that the filter locking tab was missing.The assignable root cause was determined to be due to the tab getting snagged and pulled off during processing.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported from canada that during a total hip surgery, it was observed that the tab was broken on the suction nozzle of the super sucker device.There were no delays to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The reported stated that the event occurred during the month of (b)(6) 2014; however, the exact date of the event was unknown.The reporter stated that the device was used in a canadian facility.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Additional 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.

• Brand Name: SUPER SUCKER SHORT, X50 BULK PACKED
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE - SUCTION TIP
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 4163659
• MDR Text Key: 13341575
• Report Number: 1045834-2014-13133
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK822065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 63-SS2-1
• Device Lot Number: G483087436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1