MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.15MM TWIST DR FOR 1.5 X 4MM SCW,SHD; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	SHD-1504TD-G1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation and testing.An assessment was performed and it was observed that the tip of the cutter was broken.The cutter was examined using 28x magnification.Based on the angle of the break indicates 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.The assignable root cause of this condition was determined to be component damage caused by user error.A review of the device history was performed and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi ¿ (b)(4).
Event or Problem Description
This is report 2 of 2 for the same event.It was reported that two cutting burrs had an issue being loaded into the handpiece device.During in-house engineering evaluation it was observed that the tip of the cutter was broken.This event did not occur during surgery.There was no patient involvement.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 will be submitted accordingly.

• Brand Name: 1.15MM TWIST DR FOR 1.5 X 4MM SCW,SHD
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8409734
• Report Number: 1045834-2019-53078
• Device Sequence Number: 14035034
• Product Code: HBE
• UDI-Device Identifier: 00845384015741
• UDI-Public: 845384015741
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 01/10/2019

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 Catalogue Number: SHD-1504TD-G1
• Device Lot Number: M023128889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1