MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.4MM X 12.8MM FRTR,CRNP; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number	P-CRN-G1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Concomitant medical products: 4 cutter devices.The actual device has been returned and is currently pending evaluation.Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly.  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
This is event 4 of 5 of the same event.It was reported that during a craniosynostosis surgical procedure, it was observed that five cutter devices snapped in half.According to the surgeon the cutter devices broke roughly fifteen minutes into use, without aggressively drilling.It was unknown if there were delays to the surgical procedure.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 determined that the broken tip was confirmed.The external features of the returned cutter were visually inspected and it was observed that the tip of the cutter was broken.The cutter was examined and photographed using 28x magnification.Based on the photographs taken, the angle of the break indicated that there was excessive force applied or an improper sized cutter was being used.The root cause was due to excessive lateral or side to side force or improper sized cutter was being used.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to user error.A review of the device history record 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.
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 date of manufacture was reported as feb 07, 2019 in error on the initial medwatch report.The correct date is mar 11, 2019.The udi has been updated accordingly.If additional information should become available, a supplemental medwatch report will be sent accordingly.Udi: (b)(4).

• Brand Name: 1.4MM X 12.8MM FRTR,CRNP
• 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: 8634731
• Report Number: 1045834-2019-53643
• Device Sequence Number: 1644258
• Product Code: HBC
• UDI-Device Identifier: 00845384012634
• UDI-Public: 845384012634
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2019

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: 01/07/2024
• Device Catalogue Number: P-CRN-G1
• Device Lot Number: N033135248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/29/2019; 05/20/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 05/31/2019; 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1