MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-EDGE D/A WIRE CUTTER 7

Model Number	275510
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Several attempts were made to obtain the device for inspection and investigation, but it was not returned to the manufacturer.The manufacturing lot number is unknown and it is impossible to review device manufacturing history.However, it has been established that the device was manufactured in 2016.Possibly the problem was due to normal wear over time.The complaint is considered closed.Should additional information become available, it will be reopened.
Event or Problem Description
The wire cutter was used to cut k-wire, but the ends of the k-wire frayed and small fragments broke off into the patient during surgery.The broken pieces were recovered.No patient injury occurred; however, there was an unspecified delay in surgery time.

• Brand Name: CARB-EDGE D/A WIRE CUTTER 7
• Common Device Name: WIRE CUTTER
• 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: 16465747
• Report Number: 8010168-2023-00004
• Device Sequence Number: 5063937
• Product Code: HXZ
• UDI-Device Identifier: 10381780385097
• UDI-Public: 10381780385097
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

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: 275510
• Device Catalogue Number: 275510 / OL 505-18-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown