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

Catalog Number	QD14-S-G1
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Device evaluation: the actual device was returned for evaluation.A visual and functional assessment was performed which determined that the device had excessive vibration and it was noisy (failed vibration assessment).It was further determined that the device passed the visual assessment but failed the functional assessment.During repair, it was observed that the locking mechanism and back end assembly were contaminated, and the laser etching was fading away.It was determined that the issues were consistent with normal wear.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear out from use.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
It was reported that during testing, it was observed that the attachment device was making noise.During in-house engineering evaluation, it was observed that the device had excessive vibration and it was noisy (failed vibration assessment).The event was not related to surgery.There was no patient involvement reported.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 report will be submitted accordingly.

• Brand Name: 13.5 CM QD 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: 8914968
• Report Number: 1045834-2019-54325
• Device Sequence Number: 13889918
• Product Code: HBC
• UDI-Device Identifier: 00845384016465
• UDI-Public: 00845384016465
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K133604
• 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): 07/24/2019

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: QD14-S-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1