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 Codes	Material Fragmentation (1261); 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).
Additional Manufacturer Narrative
In the case of the rejected article 26173kpf from the customer, it was determined that a part of the hard metal plate was broken off.However, during the investigation it was determined that these are very heavily worn.According to the lot, the article is from march 2020, so there are only two possibilities.Either this item has been used very often, causing the jaws to wear and the item has exceeded its life cycle, or the item has been externally machined.Because the hard metal plates no longer have teeth, they are no longer thick enough and will break if something is clamped.This can be seen clearly on the other part of the jaw that the hard metal plate no longer has any teeth and is therefore too thin, as a crack has also formed here as a result.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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17573199
• Report Number: 9610617-2023-00212
• Device Sequence Number: 8400281
• Product Code: GCJ
• UDI-Device Identifier: 04048551098219
• UDI-Public: 4048551098219
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K951625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2020
• 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