MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 2.3MM FLUTED MATCHSTICK, 15CM; DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR

Catalog Number	MA15-8N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products and therapy dates: bearing sleeve device.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 a minimally invasive discectomy (mis) surgical procedure of the spine, it was observed that the drill bit head on the cutter device separated from the stem into two separate pieces, while being used with a bearing sleeve device.It was reported that the user was able to recover both pieces and ensured that nothing was left in the patient or in the surgical field by examining under the microscope.It was also reported that the two pieces were retained.It was reported that there was a five minute delay in the surgical procedure.It was reported that the procedure was able to be completed without further use of the drill bit.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown but was noted to have occurred on 2019.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 device manufacture date was reported as unknown in the initial report and has been updated to mar 13, 2019.Device history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.3MM FLUTED MATCHSTICK, 15CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8715747
• Report Number: 1045834-2019-53859
• Device Sequence Number: 13976000
• Product Code: HBE
• UDI-Device Identifier: 00845384004592
• UDI-Public: 00845384004592
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: MA15-8N
• Device Lot Number: N063135694
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1