MAUDE Adverse Event Report: RICHARD WOLF GMBH POWER STICK M5/3; MOTOR HANDPIECE MAX. 16000RPM

Model Number 899550003

Device Problems Failure to Cut (2587); Mechanical Jam (2983)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

A health professional has informed richard wolf gmbh an issue regarding a motor handpiece max.16000rpm, part id: 899550003, serial # (b)(6).According to the received information, "when using the bench drill it stopped rotating and did not perform its function." the reported issue caused a 2 hour delay in the procedure.There was no report of risk for the patient.

Manufacturer Narrative

During the inspection of the motor handle in the specialist department in accordance with pa-01-001-8874, it was found that the bellows of the motor gear unit is severely deformed and does not run smoothly.There is an unbalance present.Motorized handle type 899550003 with serial number (b)(6) was produced on 11/17/2021 (batch 1493848 with a lot size of 15) and delivered to the customer on 11/24/2021.Review of the device history record did not identify any discrepancies or special releases.In the period under consideration, no comparable case of this type 89955.0003 with "coil - short circuit" has been registered.In general, the user is advised in the associated ga-a238-us / en / 2020-12 v6.0 / pk20-0352 instructions for use under chapter 4 that a visual and functional check must be performed before and after each use.Possible damage/malfunctions of the above type can be easily detected by hospital staff if these instructions are followed.In our risk analysis e5-2, manufacturing-related, handling-related and design-related hazards with regard to a functional impairment 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.

• Brand Name: POWER STICK M5/3
• Type of Device: MOTOR HANDPIECE MAX. 16000RPM
• 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: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17109392
• MDR Text Key: 317158171
• Report Number: 9611102-2023-00034
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K080617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 899550003
• Device Catalogue Number: 89955.0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1