MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.55MM X 10MM TWIST DR,S; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number	S-1510TD-G1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporter¿s phone number was not provided.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 or Problem Description
It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the cutting burr device broke while opening the suture hole for a dural lift.It was reported that the event occurred during use on a patient.There were no delays to the surgical procedure as a spare device was available for use.There was patient involvement reported.It was reported that the pieces of the broken device were retrieved from the patient.There were no reports of injuries, medical intervention or prolonged hospitalization.It was reported that there were no adverse consequences to the patient.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The broken tip of the cutter device was visually examined and the nature of the fracture indicated that the break was caused by excessive force during use.The assignable root cause was determined to be due to user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 1.55MM X 10MM TWIST DR,S
• Common Device Name: MOTOR, DRILL, ELECTRIC - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7105308
• Report Number: 1045834-2017-50129
• Device Sequence Number: 16488645
• Product Code: HBC
• UDI-Device Identifier: 07611819167773
• UDI-Public: (01)07611819167773(11)160705(10)K183115816
• Combination Product (Y/N): N
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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 Catalogue Number: S-1510TD-G1
• Device Lot Number: K183115816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1