MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC UNKNOWN BURRS & DRILLS; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number UNK-BURRS-&-DRILLS

Device Problems Material Fragmentation (1261); Separation Problem (4043)

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

Event Type  malfunction  

Event Description

It was reported that there was an issue with the cord of the motor device.It was reported that it was not functioning properly.During in-house engineering evaluation it was observed that a fragment of an unknown cutter device was stuck inside the handpiece device.It was noted that the small fragment was not visible when originally received.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.H10 additional narrative: device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the motor device and the reported condition that the motor device had a damaged hose was confirmed, and it was also confirmed that a piece of a broken cutter was stuck inside the motor device.The device was visually inspected as received from the customer.It was found that the device failed the visual assessment due to the cutter was fractured.The device was taken apart and it was noted that there was excessive corrosion, and medical debris in the locking mechanism assembly, which was preventing the lock tabs from releasing the cutters, which caused the failure.The piece of the cutter was examined using 28x magnification and rechecked on an optical comparator.A full assessment of the device could not be performed due to the condition of the cutter was received.The piece of the cutter was broken off below the laser marking and identification of the cutter and the lot number was not able to be identified and the rest of the cutter was not returned.The cause for cutter getting stuck was likely due to debris and residue preventing the lock tabs from moving into place.The cause of the medical debris and detergent residue buildup was due to improper cleaning.The assignable root cause of these conditions was determined to be due to improper handling, which is user error.

• Brand Name: UNKNOWN BURRS & DRILLS
• Type of Device: MOTOR, DRILL, ELECTRIC - CUTTING BURR
• 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: 16638218
• MDR Text Key: 312462268
• Report Number: 1045834-2023-00462
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-BURRS-&-DRILLS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2023
• 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: Unknown
• Patient Sequence Number: 1