MAUDE Adverse Event Report: RICHARD WOLF GMBH DOUBLE ACTION MICRO-RONGEUR

Model Number 89240.1013

Device Problem Material Separation (1562)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf (b)(4).Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Event Description

It was reported to richard wolf by the user facility through the isa that "one of the jaws broke off." additional information: will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.

Manufacturer Narrative

Follow-up report #1 is to provide fda with missing information, new information, and changed information.Device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed: intended use: the scissors are used for cutting adhesions, for preparation, for severing soft tissues, cartilage and suture material.Ifu includes a caution for limited strength.Caution! the products have only limited strength! exerting excessive force will cause damage, impair the function and therefore en­danger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Ensure that no missing instrument parts remain in the patient.Do not use products which are damaged, incomplete or have loose parts.Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint closed.We have reached out to the user facility twice for additional information about this event and so far we've not received a response.Should we receive additional information a follow-up report will be submitted.

Event Description

The results of the device investigation reveal that the "damage consistent with excess force applied to a material the rongeur couldn't break, bending the upper jaw backward until it broke.".The device was visually inspected and reported condition was confirmed.The root cause was determined to be user error.The device will be scrapped.

• Brand Name: DOUBLE ACTION MICRO-RONGEUR
• Type of Device: DOUBLE ACTION MICRO-RONGEUR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12060081
• MDR Text Key: 274083692
• Report Number: 1418479-2021-00027
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 89240.1013
• Device Catalogue Number: 89240.1013
• Device Lot Number: 1344915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1