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

Model Number 28205GE

Device Problem Fracture (1260)

Patient Problem Laceration(s) (1946)

Event Date 05/25/2023

Event Type  Injury  

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 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
• Type of Device: ORTHOPAEDIC BUR, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17549069
• MDR Text Key: 321160626
• Report Number: 2020550-2023-00207
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04048551110232
• UDI-Public: 4048551110232
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 08/15/2023
• Distributor Facility Aware Date: 08/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention