MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-BITE DEBAKEY NEEDLEHOLDER; NEEDLE HOLDER

Model Number	121186
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a heart operation, the surgeon noticed that a piece of the needle holder was missing.Before the end of the operation, an x-ray was taken.The missing piece was not found in the patient's body.Medical staff did not know at which stage the device broke, but suspected it was at the beginning of the operation.The event did not lead to patient injury, but a two-hour increase in surgery time was reported.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The following form fields have been updated: d4, d9, h2, h3, h6, h10.The device was returned to the manufacturer.Inspection of the returned device revealed that it was manufactured by another company.The manufacturer of the device is unknown.The relabeler has been informed accordingly.The investigation has been closed.

• Brand Name: CARB-BITE DEBAKEY NEEDLEHOLDER
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: hanno haug ; ludwigstaler strasse 27; tuttlingen, bw 78532 ; GM 78532
• MDR Report Key: 16110119
• Report Number: 8010168-2023-00001
• Device Sequence Number: 13958265
• Product Code: DWS
• UDI-Device Identifier: 10381780165071
• UDI-Public: 10381780165071
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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: 121186
• Device Catalogue Number: 121186 / AR 278-20-61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/07/2023
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male