MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FINISH BARREL BURR; ORTHOPAEDIC BUR, REUSABLE

Model Number	28205GE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspected device was returned and evaluation is in progress.Once the evaluation is completed, a supplemental report will be made.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that there was an issue with the product 28205ge (finish barrel burr).The distal head broke during use.According to the complaint description, the breakage of the device occured during a surgery on a bone spur.Procedure was not completed successfully.Medical diagnostical intervention was required.Surgical delay and prolongation of surgery were between 15 to 60 minutes.Adverse consequences due to failure were larger incision, greater tissue damage, longer wound healing, longer work loss.

• Brand Name: FINISH BARREL BURR
• Common Device Name: ORTHOPAEDIC BUR, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17549069
• Report Number: 2020550-2023-00207
• Device Sequence Number: 17808762
• Product Code: HRX
• UDI-Device Identifier: 04048551110232
• UDI-Public: 4048551110232
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2023
• Report Date (Section F): 08/15/2023

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: 28205GE
• Device Catalogue Number: 28205GE
• Device Lot Number: YS01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2023
• 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: Other; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/15/2023