MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 3MM FLTD MATCHSTK,EXT 8.9MM,LESS AGGRESS; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)

Catalog Number S-8NS-M

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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 (b)(6) that during a craniotomy surgical procedure, it was observed that the cutter device would not fit into the attachment device.There were no delays to the surgical procedure as a spare device was available for use.There was patient involvement.There were no reports of 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

(b)(4).The device manufacture date was documented as unknown in the initial report.It has been updated as oct 6, 2015.The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device passed all operational 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.

• Brand Name: 3MM FLTD MATCHSTK,EXT 8.9MM,LESS AGGRESS
• Type of Device: DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
• 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: 6360113
• MDR Text Key: 68360468
• Report Number: 1045834-2017-10481
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-8NS-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2015
• 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
• Treatment: ATTACHMENT DEVICE