MAUDE Adverse Event Report: KARL STORZ SE & CO. KG AGRESSIVE BARREL BURR, 5.5MM, STRAIGHT; SHAVER BLADE

Model Number	28205HDS
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation is pending.
Event or Problem Description
As per an aer received by the factory in (b)(4): the tissue protection was partially milled away from the inner blade.This resulted in numerous metal splinters, which the surgeon was able to remove with another shaver blade.
Additional Manufacturer Narrative
Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.The protection outter layer was damaged.It could be found that the damaged area was bend and a part of the outer shaver is missing.This damage is highly caused by the metal shaver blade i.E the metal shaver blade touched the outer during use.Damages like this occurs when either the shaver has been leveraged, causing the two parts to be pressed against each other or if too much force is applied to the rotating part, causing it to bend in the direction of the outer shaft.The root cause is probably due to unintended contact between protection outer and inner shaver blade during use which may have led to the metal splinters.There is no indication for a material defect or manufacturing problem.The event is filed under internal karl storz complaint id ((b)(4)).

• Brand Name: AGRESSIVE BARREL BURR, 5.5MM, STRAIGHT
• Common Device Name: SHAVER BLADE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 2188201
• MDR Report Key: 10148252
• Report Number: 9610617-2020-00069
• Device Sequence Number: 16669461
• Product Code: HRX
• UDI-Device Identifier: 04048551110300
• UDI-Public: 4048551110300
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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 Model Number: 28205HDS
• Device Catalogue Number: 28205HDS
• Device Lot Number: 81381N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2020
• 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