MAUDE Adverse Event Report: KARL STORZ SE & CO. KG AGRESSIVE CUTTER FOR UNIDRIVE S III, 4.5MM, STRAIGHT; SHAVER BLADE

Model Number	28205AK
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation is pending return of device.
Event or Problem Description
As per report filed with (b)(6), by the factory in (b)(6): during a knee arthroscopy procedure, iron came out of the distal part of a 28205aks shaver blade.
Additional Manufacturer Narrative
The provided products show no defect, which could cause metal chips to be created -the appear brand new without any unusual use marks.The described metal chips are most likely from another device.
Additional Manufacturer Narrative
Data in section h6 have been corrected to match the evaluation findings.

• Brand Name: AGRESSIVE CUTTER FOR UNIDRIVE S III, 4.5MM, STRAIGHT
• Common Device Name: SHAVER BLADE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 9933613
• Report Number: 9610617-2020-00040
• Device Sequence Number: 2596163
• Product Code: HRX
• UDI-Device Identifier: 04048551109823
• UDI-Public: 4048551109823
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K030009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2022

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 Expiration Date: 12/31/2023
• Device Model Number: 28205AK
• Device Catalogue Number: 28205AKS
• Device Lot Number: 78261N
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/09/2020; 08/11/2022
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 08/09/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown