MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1MM FBALL,ST,L; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number	L-1SB-G1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (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 additional information should become available, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported that during an unspecified surgical procedure, it was observed that the cutter device broke into two.According to the reporter, both pieces were removed.It was unknown if there were any delays in the surgical procedure or if 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
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the reported condition that the device had a broken tip was confirmed.The external features of the returned cutter were visually inspected.There was black discoloration on the tip which indicated insufficient irrigation during the procedure contrary to dfu (directions for use).The cutter was examined and photographed using 28x magnification.Based on the photographs taken the angle indicated that there was excessive force applied.The assignable root cause was traced to the user from excessive lateral or side to side force.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 1MM FBALL,ST,L
• 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: 9157007
• Report Number: 1045834-2019-54624
• Device Sequence Number: 11277010
• Product Code: HBC
• UDI-Device Identifier: 00845384014553
• UDI-Public: 00845384014553
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K011444
• 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): 09/20/2019

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 Expiration Date: 12/31/2021
• Device Catalogue Number: L-1SB-G1
• Device Lot Number: K463120066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1