MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SUTURING NEEDLE HOLDER, REUSABLE; MACRO NEEDLE HOLDER, 5 MM, 33 CM

Model Number	26173KPF
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a part of the jaw was missing during the surgery.The fragment was probably left in the patient's body.Additional surgery is required to remove part of the needle holder.
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SUTURING NEEDLE HOLDER, REUSABLE
• Common Device Name: MACRO NEEDLE HOLDER, 5 MM, 33 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17573198
• Report Number: 2020550-2023-00212
• Device Sequence Number: 8400280
• Product Code: GCJ
• UDI-Device Identifier: 04048551098219
• UDI-Public: 4048551098219
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2023
• Report Date (Section F): 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26173KPF
• Device Catalogue Number: 26173KPF
• Device Lot Number: PP05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/16/2023
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown