MAUDE Adverse Event Report: GYRUS ACMI, INC BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number BUR4070DT

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation, the user¿s request was unable to be replicated.During visual inspection, some minor wear was noted on the distal end and reddish foreign material near the middle of the outer blade implying that the device has been used.No other observations were found, no wobble or vibrations from the device.The device history records (dhr) for this product have been reviewed.All records indicate that the product was manufactured, tested in accordance with all applicable procedures, and met all final product release criteria.Per the testing procedures (electrical, torque, bending), the blades are tested for electrical and physical tolerances while remaining functional.Based on the testing procedures and dhr, it is likely that the damages incurred were likely during transportation or use.Olympus will continue to monitor complaints for this device through regular trending activities as defined by osta qms procedure.

Event Description

The user facility reported that the diamond taper blade stopped working.The registered nurse at the user facility reported that the issue occurred during the middle of a therapeutic procedure.The intended procedure was completed with no delay using a different similar device.The device had no anomalies, cable damage nor error messages.No patient injury was reported.No additional information has been obtained.

• Brand Name: BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 2925 appling rd; bartlett, TN 38133 ; 9013785969
• MDR Report Key: 10361692
• MDR Text Key: 207370831
• Report Number: 1037007-2020-00028
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT-EQJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2020

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
• Device Operator: Health Professional
• Device Model Number: BUR4070DT
• Device Lot Number: NC803072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1