MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 10.5CM ANGLE ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number	QD11-S
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition that the attachment would not hold the cutter was not confirmed.However, during evaluation, it was determined that the device failed vibration assessment which was determined to be due to normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported that the attachment device would not hold the cutter device.During in-house engineering evaluation, it was determined that during temperature testing, the device was too noisy, and the set screw didn't pass the test, it was loose and failed the thimble set screw assessment and vibration assessment.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 10.5CM ANGLE ATTACHMENT
• Common Device Name: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9180763
• Report Number: 1045834-2019-54669
• Device Sequence Number: 2657520
• Product Code: HBC
• UDI-Device Identifier: 00845384006381
• UDI-Public: 845384006381
• Combination Product (Y/N): N
• 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): 09/06/2019

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: QD11-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1