MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 3MM FMSTK,L AGG,L; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	L-8NS-M-G1
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
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 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 report 3 of 4 for the same event: it was reported by the surgeon that during an anterior cervical discectomy and fusion (acdf) surgical procedure, it was discovered that the motor device started heating up while being used together with the attachment and cutter device.According to the surgeon, the staff replaced the first cutter device with a second similar cutter.It was further reported that the motor device stopped and was replaced with a second similar device.The procedure continued.The surgeon stated that it was determined later in the case that the patient received a burn at the wound site, suggesting the motor device heating up may have caused the event.It was reported that the surgeon did use electro cautery on his procedures.It was not reported if there were any delays in the surgical procedure.It was reported that there was no additional treatment performed and the patient was discharged the following day as planned.There was patient involvement reported.It was reported that there was no prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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.Udi:(b)(4).Correction: incorrect device manufacture date: the device manufacture date was incorrect in the initial report.The device manufacture date has been updated from 12/19/2018 to 1/10/2019.Device history review, complaint history review: 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 non-conformance's or abnormalities identified during the manufacture of the device that may have contributed to the reported condition.Complaint history review: a complaint history review was performed which indicated that there were no complaints filed against the reported lot number.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3MM FMSTK,L AGG,L
• 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: 8522592
• Report Number: 1045834-2019-53385
• Device Sequence Number: 1871087
• Product Code: HBE
• UDI-Device Identifier: 00845384012511
• UDI-Public: 845384012511
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: L-8NS-M-G1
• Device Lot Number: M453134249
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MOTOR DEVICES, ATTACHMENT DEVICE, CUTTER DEVICE; MOTOR DEVICES, ATTACHMENT DEVICE, CUTTER DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 109