MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG VITAL WIRE CUTTER DBL-ACT ANG SIDE CUT

Catalog Number OS3052-001 (OL 505-16-01)

Device Problem Material Fragmentation (1261)

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

Event Date 04/27/2023

Event Type  malfunction  

Manufacturer Narrative

The device was subject to excessive stress during use, causing the jaw insert to fracture.

Event Description

The tungsten carbide jaw of the device broke during percutaneous pinning of a finger.An x-ray was taken to ensure that no device fragments had fallen into the surgical field.The procedure was completed as planned and patient outcome was good.

• Brand Name: VITAL WIRE CUTTER DBL-ACT ANG SIDE CUT
• 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: 17102103
• MDR Text Key: 317828880
• Report Number: 8010168-2023-00005
• Device Sequence Number: 1
• Product Code: HXZ
• 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: 06/09/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: OS3052-001 (OL 505-16-01)
• Device Lot Number: J22XBF
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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