MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 5CM HEAVY DUTY SHORT ATTACHMENT; MOTOR, DRILL, ELECTRIC

Model Number	SHORT-HD
Medical Device Problem Codes	Vibration (1674); Excessive Heating (4030)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.  quality engineering evaluated the device and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to maintenance deficiency.Concomitant medical products and therapy dates: motor device; (b)(6) 2020.(b)(4).
Event or Problem Description
It was reported that during an unspecified surgical procedure, the attachment device would not seat or lock appropriately while being used with a motor device.It was reported that the procedure was delayed 5-10 minutes while trouble shooting and opening a spare drill device.During in-house engineering evaluation, it was determined that the device had heat and vibration, the device was worn, had corrosion/rusting/pitting, and the color band chipping/fading.It was further determined that the device failed pre-test for color band fading, vibration and temperature.It was reported that the device was used in surgery and there was 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: 5CM HEAVY DUTY SHORT ATTACHMENT
• Common Device Name: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10671215
• Report Number: 1045834-2020-01689
• Device Sequence Number: 16784569
• Product Code: HBC
• UDI-Device Identifier: 00845384008804
• UDI-Public: 00845384008804
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

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: SHORT-HD
• Device Catalogue Number: SHORT-HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1