MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 8 CM SHORT,QD ANGLE ATTACHMENT; MOTOR, DRILL, ELECTRIC

Catalog Number QD8-G1

Device Problems Overheating of Device (1437); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.An evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was traced to environmental issues.(b)(4).

Event Description

It was reported from (b)(6) that during service and repair/pre-testing, it was observed that the attachment device overheated and the bearing was worn.It was further noted that the device failed pretests for temperature assessment (elbow temperature), temperature assessment: (highest recorded), temperature assessment (highest recorded temperature) and temperature assessment (highest device temperature).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 but was known to have occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 8 CM SHORT,QD ANGLE ATTACHMENT
• Type of Device: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6107428552
• MDR Report Key: 11041201
• MDR Text Key: 222777086
• Report Number: 1045834-2020-02166
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 00845384016373
• UDI-Public: 845384016373
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K133604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: QD8-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 12/15/2020
• Date Device Manufactured: 03/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1