MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. AGGRESSIVE BARREL BURR, STERILE, 6X; ORTHOPAEDIC BUR, SINGLE-USE

Model Number 28205HCS

Device Problems Material Fragmentation (1261); Particulates (1451)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

The event occurred in germany.It was reported that the handpiece causes metal abrasion during arthroscopy.No further information is available beyond this.No negative impact on the state of health was reported.The error description does not provide information on whether metal fragments fell and/ or remained in the patient's body or not.Additional patient information is not available.

Manufacturer Narrative

The device in question was not returned by the customer.The remaining unused items 28205hcs of the pack were returned by the customer show no signs of abrasion, contamination or production-related defects.Unfortunately, the items complained about by the customer were disposed of by hospital staff after the operation, so it was not possible to carry out a detailed examination on the instruments concerned.As described in ifu 96156018d, the burr must not be put into operation without rinsing, as this can lead to overheating and abrasion on the running surfaces.The flushing also acts as a coolant and lubricant for the running surfaces of the cutter.If this fluid is missing, the customer's described error pattern may occur.A too high selected speed or pressure on the milling cutter can also cause this error pattern.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: AGGRESSIVE BARREL BURR, STERILE, 6X
• Type of Device: ORTHOPAEDIC BUR, SINGLE-USE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave; el segundo CA 90245 5017
• Manufacturer (Section G): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave; el segundo CA 90245 5017
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 16437111
• MDR Text Key: 310262266
• Report Number: 1221826-2023-00046
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28205HCS
• Device Catalogue Number: 28205HCS
• Device Lot Number: 85014N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1