MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.12MM X 6.35MM FRTR,SHD; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)

Model Number	SHD-6R-G1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the tip of the cutter was broken.Evaluation of the device determined that there was excessive force applied.The root cause of the customer¿s complaint that ¿cutters broke¿ was excessive lateral or side to side force.Forceful side loading of cutting burrs may cause fracture of dissecting tool.Therefore, the assignable root cause was determined to be due to user error.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported that during an unspecified surgical procedure, it was observed that the cutter device broke.There were no delays in the surgical procedure.It was not reported whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
The device manufacture date was reported as september 18, 2017 and has been updated to september 13, 2017.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: 1.12MM X 6.35MM FRTR,SHD
• Common Device Name: DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7164592
• Report Number: 1045834-2018-50014
• Device Sequence Number: 1863497
• Product Code: HBE
• UDI-Device Identifier: 00845384012887
• UDI-Public: (01)00845384012887(11)170918(10)L233124469
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K113476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2017

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
• Operator of Device: Health Professional
• Device Model Number: SHD-6R-G1
• Device Catalogue Number: SHD-6R-G1
• Device Lot Number: L233124469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Initial Date Received by Manufacturer: 12/09/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1