MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 3 MM FLUTED MATCHSTICK; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number S-8NS-G1

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

Reporter's phone number was not provided.The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the device met all manufacture's specifications.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during an unspecified pediatric surgical procedure it was observed that the attachment device had a dirty oil substance leaking out of the distal end.The reporter stated that the surgical site was irrigated and then frasier suctioned.During in-house engineering evaluation, it was determined that a cutter device was stuck inside the attachment device.It was reported that there was a fifteen minute delay in the procedure due to the event and an unspecified spare device was available for use.The procedure was successfully completed.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 3 MM FLUTED MATCHSTICK
• Type of Device: MOTOR, DRILL, ELECTRIC - CUTTING BURR
• 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: 5506754
• MDR Text Key: 40831260
• Report Number: 1045834-2016-10767
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK113476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: S-8NS-G1
• Device Lot Number: J373109739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1