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

Model Number 275510

Device Problem Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 310495361
• Report Number: 8010168-2023-00004
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10381780385097
• UDI-Public: 10381780385097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 275510
• Device Catalogue Number: 275510 / OL 505-18-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention