MAUDE Adverse Event Report: AESCULAP INC HI-LINE XS SIDE CUTTING, TC 1, 2.0 MM; HIGHSPEED POWER SYSTEMS

Model Number	US221
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was an issue with a burr.The device broke while being used in a cranio-maxillofacial surgery.The fragment, which had fallen in the surgical field, was removed without any harm to the patient.There was a five minute delay due to the reported event.Anoother burr was opened in order to complete the procedure.Additional information has been requested.
Additional Manufacturer Narrative
Correction - evaluation: device manufacture date 5/7/2020; quantity 55.Device history records (dhr) - the dhr review did not reveal any abnormalities in the manufacturing process.Non-conformance and trending review - this has been determined to be an isolated incident based on the defect rate of 0.01% (100 dpm).Containment - there was 1 additional lot manufactured after the affected lot.There were also no manufacturing abnormalities observed during manufacture.There were zero (0) internal ncmrs generated, and zero (0) customer complaints recorded.There is no other product potentially affected.Failure investigation - root cause is unknown and there was no manufacturing error.All dimensional measurements (in-process and final inspection) were within specification.A review of the material certifications showed that the material was within specification.A literature search on carbide material was also performed.Carbide is classified as a brittle material as it exhibits little to no plastic deformation before the initiation of a total failure.Improper handling of the device during use many cause failure.Correction and/or preventive action - no specific corrective actions are deemed required.Disposition - product was not returned nor received.

• Brand Name: HI-LINE XS SIDE CUTTING, TC 1, 2.0 MM
• Common Device Name: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 11592120
• Report Number: 2916714-2021-00045
• Device Sequence Number: 16912081
• Product Code: GET
• UDI-Device Identifier: 04046955073962
• UDI-Public: 4046955073962
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: US221
• Device Catalogue Number: US221
• Device Lot Number: 358575
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention