MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOOK AND RETRACTOR

Model Number	28145W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned; no investigation results so far.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(4).The hook broke off during knee arthroscopy.It was used for arthroscopic examination and elevation.
Additional Manufacturer Narrative
Data in section h6 have been corrected to match the evaluation findings.
Additional Manufacturer Narrative
Upon evaluation, the product was clearly bent and broken into 2 pieces.There is no signed of corrosion.The damaged is due to user handling related such as abuse or misuse.There is no patient harm reported.Based on assessment criteria, this is not reportable case.

• Brand Name: HOOK AND RETRACTOR
• Common Device Name: HOOK AND RETRACTOR
• 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 90245-5017 ; 4242188201
• MDR Report Key: 10962896
• Report Number: 9610617-2020-00125
• Device Sequence Number: 11422097
• Product Code: LXH
• UDI-Device Identifier: 04048551095607
• UDI-Public: 4048551095607
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 08/10/2022

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 Model Number: 28145W
• Device Catalogue Number: 28145W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 10/23/2020; 08/10/2022
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 08/08/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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