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

Model Number	QD14-S-G1
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, an evaluation was performed and it was determined that the device ran in locked position.It was further determined that the mid assembly, locking mechanism, and back end subassembly had corrosion.It was observed that the device had a cosmetic damage ¿ worn.It was further determined that the device failed pretest for cutter brake assessment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.(b)(4).
Event or Problem Description
It was reported that during service and repair pre-testing, it was discovered that the attachment device ran in locked position.The event was not related to surgery.There was no patient involvement.There were no injuries or medical intervention associated with this event.The exact date of the event was unknown.However, it was reported that the event occurred in 2020.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
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10393222
• Report Number: 1045834-2020-01277
• Device Sequence Number: 2898304
• Product Code: HBC
• UDI-Device Identifier: 00845384016465
• UDI-Public: 00845384016465
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

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: 07/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1