MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC COMPACT SPEED REDUCER, 60:1; MOTOR, DRILL, PNEUMATIC

Model Number CSR60

Device Problems Vibration (1674); Mechanical Jam (2983); Excessive Heating (4030)

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

Event Date 01/01/2022

Event Type  malfunction  

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.Additional narrative: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition of the device not working properly, wobbling, and exhibiting vibration were not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device generating heat, identified during service and evaluation was confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).

Event Description

It was reported by (b)(6) that during service and evaluation, it was determined that the compact speed reducer device generated heat.It was further determined that the device failed pretest for temperature.It was noted in the service order that during pre-surgery, it was discovered that the device was not working properly and was wobbling while using the perforator attachment.It was further reported that the device exhibited excessive uncomfortable vibration.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in (b)(6) 2022.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: COMPACT SPEED REDUCER, 60:1
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 14186243
• MDR Text Key: 289862033
• Report Number: 1045834-2022-00484
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 00845384001782
• UDI-Public: 00845384001782
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K960630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSR60
• Device Catalogue Number: CSR60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2022
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2018
• 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