MAUDE Adverse Event Report: RICHARD WOLF GMBH POWER STICK M4; MOTOR HANDPIECE MAX. 6000RPM

Model Number 8564021

Device Problems Overheating of Device (1437); Noise, Audible (3273)

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

Event Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

During the inspection of the motor handpiece max.6000rpm type 8564.021, serial # (b)(6) by richard wolf gmbh, the customer complaint "a strange noise, gets hot when working and does not work properly" could not be reproduced.The running noises are in a normal range and the temperature is also normal after an endurance test.As well as the motor handle has its torque under load.Visual inspection of the motor handle has revealed that the contact pins on the plug are corroded.Cleaning error by the user.After consultation with the technical department, the instructions for use were not followed by the user.The user is advised in the supplied instructions for use ga-a238 / es / 2020-10 v10.0 / pk20-0257 / under chapter 6 to operate the rotary blades / burrs only in liquid.The cooling of the tissue as well as the tool must be ensured by providing adequate irrigation.The information on intermittent operation must also be observed, as otherwise the grip surface of the motor handle may heat up considerably.The user's attention is also drawn to the limited stability of the products in chapter 6.4.Excessive force applications lead to damage, impair the function and thus endanger the patient.In addition, an equivalent replacement must be available in accordance with chapter 2.7 due to possible instrument or device failure, during therapeutic use.The products that are damaged or have a functional impairment must no longer be used.If functional impairments occur during surgical use, this does not automatically lead to an increased risk to the patient.Intraoperatively, it leads to a short interruption until the defective motor handle is replaced.To the best of our knowledge, this corresponds to standard practice.The motor handpiece max.6000rpm type 8564.021, serial # (b)(6) was produced on (b)(6) 2022, the production order consisted of 20 handpiece.The subject motor handpiece was delivered to the customer on (b)(6) 2023.In the review period of (b)(6) 2020 and (b)(6) 2023, there was no similar complaint regarding strange noises or becomes hot during use.In general, the user is informed in the associated ifu ga-a238 / en / 2020-10 v10.0 / pk20-0257 / under chapter 5 that a visual and functional check must be carried out before and after each use.In addition, error messages are explained in chapters 6.5 and 9.1 in this ifu.The user is also advised of the correct application and the limited stability of the products in chapters 2.7 and 6.4.As well as the user is advised in the ga-a238 under chapter 8 on the proper reprocessing and maintenance of the products.Due to possible sporadic failures, the user is informed in chapter 2.7 of the ga-a238 that an equivalent replacement must be available for therapeutic applications.In our risk analysis e5-2, rev.07 (motor handles/ attachments), manufacturing-related, handling-related and design-related hazards with regard to a functional impairment, such as failure of functional parts, as well as risks due to an unusable product with the corresponding extent of damage and the assumed probability of occurrence were considered and assessed with an acceptable risk.

Event Description

The user facility has informed richard wolf gmbh of an issue regarding a motor handpiece max.6000rpm, part id: 8564.021, sn # (b)(6).According to the received information, the handpiece makes a strange noise, becomes hot during operation and does not function properly.The scheduled procedure was completed and no additional, unforeseen medical measures had to be taken.However, there was an approximately 2 hour time delay in the operating room.There is no report of injury to the patient or other personnel.No unexpected side effects and the general health condition of the patient is good.

• Brand Name: POWER STICK M4
• Type of Device: MOTOR HANDPIECE MAX. 6000RPM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: vatceslav gerdt ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 18066595
• MDR Text Key: 327302876
• Report Number: 9611102-2023-00064
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 04055207017982
• UDI-Public: 04055207017982
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8564021
• Device Catalogue Number: 8564.021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 78 KG