MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 13.5 CM QD ANGLE ATTACHMENT; MOTOR, DRILL, ELECTRIC - HANDPIECE

Model Number	QD14-S-G1
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices and therapy dates, attachment device, therapy date unknown.This device was returned for evaluation; however, during pre-repair assessment, it was determined that the device passed all operational specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
This is report 2 of 2 for the same event.It was reported from (b)(6) that during pre-surgery, two attachment devices were overheating.This event did not occur during surgery.There was no patient involvement.There were no reports of 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.

• Brand Name: 13.5 CM QD ANGLE ATTACHMENT
• Common Device Name: MOTOR, DRILL, ELECTRIC - HANDPIECE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9671325
• Report Number: 1045834-2020-00210
• Device Sequence Number: 18932835
• Product Code: HBC
• UDI-Device Identifier: 00845384016465
• UDI-Public: 00845384016465
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K133604
• 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
• Report Date (Section B): 01/22/2020

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 Model Number: QD14-S-G1
• Device Catalogue Number: QD14-S-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1