MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BEARING SLEEVE, 15CM CURVED; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	MA-15C
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Concomitant med products and therapy dates: bearing sleeve device, attachment devices, motor device, (b)(6) 2021.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
Event or Problem Description
This is report 5 of 5 of the same event: it was reported that during an unspecified surgical procedure, it was discovered that the attachment device became very hot, causing the surgeon to suffer from a first-degree burn to the finger.It was reported that the motor device was heating up while connected to the attachment and the bearing sleeve device; and the attachment became too hot to touch, burning the surgeon¿s finger.It was further reported that the burnt finger draped while the surgeon tried to switch to a different attachment device, which was also connected to a bearing sleeve.The reporter clarified that they did not know whether a malfunction occurred with the attachment devices because since the drill was hot, the attachments were never changed and therefore, were never checked for any malfunctions.It was reported that there was less than a thirty-minute delay to the surgical procedure.There was patient involvement reported.It was reported that there was no harm to the patient.It was reported that the surgeon did not receive any treatment.There were no reports of medical intervention or 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
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: h6: 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 was a non-conformance associated with this device which was unrelated to the reported malfunction.All the issues identified were resolved and the device met inspection requirements, certification test values, and acceptance criteria prior to product release.

• Brand Name: BEARING SLEEVE, 15CM CURVED
• 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: 12053273
• Report Number: 1045834-2021-00980
• Device Sequence Number: 17248702
• Product Code: HBE
• UDI-Device Identifier: 00845384004325
• UDI-Public: 00845384004325
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K042783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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 Model Number: MA-15C
• Device Catalogue Number: MA-15C
• Device Lot Number: K143115534
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention