MAUDE Adverse Event Report: MEDTRONIC DOMINICANA XPS® BUR; BUR, EAR, NOSE AND THROAT

Model Number	3127655
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: visually, the bur was returned in 3 fragments.Two portions of the shaft that were returned measured 0.62 and 1.68 inches, and the tip measured 0.19 inches in length.Under magnification contamination was observed compacted onto the tip and a brownish colored residue on both portions of the shaft.The outside diameter of the tip shall be 0.197 ± 0.003 inches, and the actual measurement was 0.194 inches which was in specification.The outside diameter of the shaft shall measure 0.0923 ± 0.0003 inches, and the actual measurements, for the smaller portion, were between 0.0920 and 0.0921 inches and, for the larger portion, 0.0920 and 0.0923 which were all in specification.Functionally, the device failed due to the damaged condition upon return and the inability to load the device into a handpiece.A review of the global complaint data showed no other complaints about this lot number.In the returned condition, there was an out of specification condition that was related to the complaint, due to physical damage.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during surgery, an ear drill was used to grind the mastoid process of the temporal bone, and the drill bit broke and the fragments did not fall into the body but fell on the operating table or the ground and a small part of the fragments were directly sucked away by the negative pressure suction device.Intervention performed has been performed.There was a procedure delay but the extended time was uncertain.The procedure was completed with backup products.There was no patient injury.

• Brand Name: XPS® BUR
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 20788354
• Report Number: 9612501-2024-02993
• Device Sequence Number: 7809407
• Product Code: EQJ
• UDI-Device Identifier: 00763000035853
• UDI-Public: 00763000035853
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 3127655
• Device Catalogue Number: 3127655
• Device Lot Number: 0223918846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown