MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SUBCUTANEOUS FASCIA CLOSURE DEVICE

Model Number	26173AM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per medwatch report #mw5110030 received via email on 6/15/22: karl storz 26173am berci fascial closure device, 2.8 mm x 17 cm, lot # he 2, tip broke off intraoperatively while closing surgical wound.
Additional Manufacturer Narrative
We have received no further details of the event, and the device has not been returned for evaluation.Per the reported lot code (he2), the device was manufactured in aug.2005; per our records, the customer was shipped the device on october 20, 2005.The damaged/broken tip was most likely due to use of excessive force and/or wear of use.A complaint review for similar articles for the timeframe 15-jun-2020 to 17-jun-2022 was performed.Similar complaints could be found; in one case the tip remained in patient and, therefore, an mdr was filed.Consequently, it is required to file a 3500a medwatch report to the fda for this case.
Event or Problem Description
Further details provided by the customer: there was no patient harm.The procedure was a lap nissen.The surgeon was a retrieving the suture by going through the fascia and the tip broke off.The tip was retrieved and x-rays were taken to verify the complete piece/pieces were removed, as well as a ct scan before the patient left the hospital.
Additional Manufacturer Narrative
The product was returned and evaluated.The evaluation confirmed one of the jaws is missing, there is residue at the jaw hinge, there are gouges on the port, and the shaft is slightly bent.Damages are consistent with use of excessive force, wear of use, as well as improper handling.

• Brand Name: SUBCUTANEOUS FASCIA CLOSURE DEVICE
• Common Device Name: SUBCUTANEOUS FASCIA CLOSURE DEVICE
• 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: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15003860
• Report Number: 9610617-2022-00118
• Device Sequence Number: 11166055
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 4048551097755
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K942612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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: 26173AM
• Device Catalogue Number: 26173AM
• Device Lot Number: HE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2005
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown