MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 7MM FLUTED BALL; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number S-7B

Device Problem Naturally Worn (2988)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 from australia that during an unspecified surgical procedure, it was observed that the cutter device was blunt.It was unknown if there were any delays to the surgical procedure.A spare identical device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The date of event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 7MM FLUTED BALL
• Type of Device: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• 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: 6650563
• MDR Text Key: 77866050
• Report Number: 1045834-2017-11349
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-7B
• Device Lot Number: K333117824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2016
• 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