MAUDE Adverse Event Report: RICHARD WOLF GMBH SERRATED SCALLOPED RESECTOR (RESECTOR TOOTHED Ø 3.5MM FOR USE WITH POWER DRIVE A

Model Number	89975.0033
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the device is on-going and a follow up report will be submitted when the investigation is complete.
Event or Problem Description
On september 05, 2019, richard wolf (b)(4) received the following information: in the course of a knee arthroscopy, the inner part of the shaver broke.During shaving in the notch area of the hoffa's (infrapatellar) fat pad (hfp), the shaver malfunctioned and inspection of the blade revealed that the tip had broken off.The fragment could not be recovered arthroscopically and remained in the patient.X-ray control examinations were carried out.
Additional Manufacturer Narrative
The resector was returned to richard wolf gmbh (rw gmbh) for further investigation.In the visual examination, it was found that the stem of the resector was bent by strong pressure being applied on the cutting window.The head of the inner blade was broken and missing.The conclusion of the investigation indicated a handling error.The product was not used as intended.The user is informed in the instructions for use about the correct application of the product.Excessive force application may result in breakage or damage to the product, which may affect its function.Furthermore, the user is advised to carry out a visual inspection and a functional check after each reprocessing and before each use.The user is advised that no missing parts should remain in the patient.A closer examination of the complaint database was carried out from 01.01.2016 to 05.09.2019.During this period (b)(4) resectors (899750033) were sold, and during the period under review there were no further complaints.A product or batch problem is therefore not recognizable.This is an isolated case.Potential hazards were taken into account in risk assessment e5-4 rev.04 with the corresponding severity of harm and probability of occurrence and assessed with an acceptable risk.This rating is still valid considering the current case.The reported issue does not describe a general product problem, non-conformity, negative trend or hitherto unknown hazards.Since the complaint relates to a handling error, a systemic problem is not recognizable and the instructions for use contains adequate warnings relating to the problem described by the customer, no further action is warranted other than the continued monitoring of complaints so that any possible trends can be identified.This case is considered closed, should additional information become available, a follow up report will be submitted.

• Brand Name: SERRATED SCALLOPED RESECTOR (RESECTOR TOOTHED Ø 3.5MM FOR USE WITH POWER DRIVE A
• Common Device Name: RESECTOR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 9263620
• Report Number: 9611102-2019-00030
• Device Sequence Number: 16243091
• Product Code: HWE
• UDI-Device Identifier: 04055207038253
• UDI-Public: 04055207038253
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 89975.0033
• Device Catalogue Number: 89975.0033
• Device Lot Number: 2704201603
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/28/2020
• 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; Required Intervention