MAUDE Adverse Event Report: JOIMAX GMBH TESSYS DISPOSABLE ACCESS KIT; ORTHOPEDIC GUIDEWIRE

Model Number TGWS40007

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

The damaged guidewire was returned to the manufacturer, decontaminated, and evaluated.Visual inspection confirmed the reported complaint issue of guidewire fracture.Sem analysis (300x) of the fracture zone revealed the fracture had initiated in a high tension area; however, there were no signs of material inhomogeneity or surface damage in or around the fracture area.Microscopic views revealed the fracture was caused by an overload and not embrittlement or material degradation.The investigation concluded that the there was no indication of a device manufacturing or quality issue and the event was most likely attributed to use error.The guidewire labeling includes the following warning statements: "make sure that the guide wire is not bent during application.A damaged guide wire, e.G.Due to bends, may no longer be used.When inserting the guide rod over the guide wire, avoid jerky forces, such as those potentially occurring when using a hammer, as otherwise shearing forces can lead to the shearing off of the guide wire".Manufacturer reference #: (b)(4).

Event Description

During preparation of endoscopic access to a lumbar disc herniation, a portion of the guidewire sheared off inadvertently.The guidewire fragment was unable to be retrieved and remains implanted in the patient.The procedure was repeated and the surgery was completed successfully.Postoperatively, an x-ray examination was performed and the patient was monitored for signs of discomfort or dislocation.The treatment plan was to leave the remaining guidewire fragment in the patient unless the patient became symptomatic.Additional information has been requested, but no further information was disclosed.

• Brand Name: TESSYS DISPOSABLE ACCESS KIT
• Type of Device: ORTHOPEDIC GUIDEWIRE
• Manufacturer (Section D): JOIMAX GMBH; amalienbadstrasse 41; raumfabrik 61; karlsruhe, 76227 ; GM 76227
• Manufacturer (Section G): ENDOSMART GESELLSCHAFT FÜR MEDIZINTECHNIK GMBH; lorenzstr. 6; stutensee, ; GM
• Manufacturer Contact: rainer steegmueller ; amalienbadstrasse 41; raumfabrik 61; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7651534
• MDR Text Key: 112788801
• Report Number: 3005083075-2018-00001
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2018

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?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2021
• Device Model Number: TGWS40007
• Device Catalogue Number: TDAK0020
• Device Lot Number: 997839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR