MAUDE Adverse Event Report: RICHARD WOLF GMBH RESECTOR TOOTHED Ø 2MM

Model Number	899710032
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During wrist arthroscopy, the shaver (inner knife) broke off distally in the area of the wrist capsule.Under x-ray control, the broken piece was removed.According to the attending surgeon, this required an additional 45-60 minutes.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of (b)(4) (device manufacturer).A follow-up report will be submitted when the device investigation has been completed.
Additional Manufacturer Narrative
New information: b4, d4, g3, g6, h2, h3, h6 (clinical code, impact code, type of investigation, investigation findings, investigation conclusions), and h10.Corrected data: d2 (common device name), d9(date returned to manufacturer), and h1(type of reportable event).Additional information was received from the user claiming that within a few months, another comparable case (subsequent mdr 9611102-2022-00044, (b)(4)) occurred with a resector from the same batch.In both cases, the inner knife got caught in the window of the outer knife during the rotational movement.Due to the abrupt stop of the inner knife, the load limit was subsequently exceeded and ultimately a section broke off.In both cases, the section could be removed from the patient.During the inspection of the resector toothed ø 2mm 899710032, batch # 0608202102 by richard wolf gmbh, it is determined in accordance with test instructions that the section broke off due to using excessive force and pressure on the device.The resector toothed ø 2mm 899710032, batch # 0608202102 was produced on 06/aug/2021, the batch consisted of 22 resectors.In total, 4 resectors were delivered to the customer, last delivery of 2 resectors was on (b)(6) 2022.In the review period of (b)(6) 2019 and (b)(6) 2022, there was no further complaints regarding the resectors except the 2 complaints from this user.The ifu ga-a238-us / en / 2020-12 v6.0 / pk20-0352 contains several safety notes of avoiding excessive force in use of the device in section 1.5 general notes and instructions for use and in section 5.4 operation of device.The subject issue of avoiding excessive force in use of the device is present in the risk management file e5-4 - reusable tools, rev.05.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: RESECTOR TOOTHED Ø 2MM
• Common Device Name: RESECTOR TOOTHED Ø 2MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, ; GM
• MDR Report Key: 14787266
• Report Number: 9611102-2022-00024
• Device Sequence Number: 5050724
• Product Code: HWE
• UDI-Device Identifier: 04055207038154
• UDI-Public: 04055207038154
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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
• Operator of Device: Other
• Device Model Number: 899710032
• Device Catalogue Number: 89971.0032
• Device Lot Number: 0608202102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown