MAUDE Adverse Event Report: RICHARD WOLF GMBH INTRADISC FORCEPS Ø 5.2MM WL 244MM; INTRADISC FORCEPS COLOR CODE WHITE, TL 393MM WITH IRRIGATION CONNECTION REUSABLE

Model Number 8792623

Device Problem Material Fragmentation (1261)

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

Event Date 02/22/2022

Event Type  malfunction  

Event Description

It was reported to richard wolf that "rongeur broke during a regular lumbar endoscopic discectomy resulting in unability to grasp.The instrument was replaced with an older substitute that was in reserve.This led to a delay of the surgery of 30 minutes.The procedure was completed with no injury for patient or user.".

Manufacturer Narrative

The manufacturer reports: "the instrument was initially sent in as a repair exchange to have the forceps replaced with new ones.In the process, the defective joint pin was disposed of and cannot be examined further.Subsequently, the customer declared it a warranty check and complained that the forceps broke apart during the first use.Further information was then requested and it was reported that the replacement of the forceps was delayed by 30 minutes.There was no patient hazard.The 8792623 intradiscal pliers ø 5, 2 mm nl 244 mm comes from the batch 1416228 and was booked on 01.08.2019 in stock.The 8792623 intradiscal nose pliers ø 5, 2 mm nl 244 mm was delivered to the user on (b)(6) 2022.According to the production control plan, there was no abnormality for the affected instrument.In our opinion, the cause is due to excessive use of force.Due to the indication and the intended field of application, the main requirement for such forceps is that they can be inserted through the smallest of openings and used in the tightest of spaces.To meet these requirements, the design of such delicate instruments requires the use of components with very small dimensions.This means that the instruments have limited stability despite the use of state-of-the-art materials.In ga-b223, the user is instructed to perform a visual and functional check after each and before each use.Visual and functional check before each use.Possible damage or functional impairment is thus detected before use, the pliers are sorted out and no longer used.Likewise, both the ga-b223 instructions refer to the proper preparation and care of the products.In addition, reference is made to the limited stability of the products.Excessive use of force will damage the product and impair its function.Ga-b223 also points out the limited stability of the products.Excessive use of force will damage the product and impair its function.Manufacturing-related and handling-related hazards, which can lead to functional impairments through which can lead to functional impairments due to damage, were taken into account in the and have been assessed as an acceptable risk.Acceptable risk.However, these assessments represent the worst case and are in no way are in no way comparable with the complaint described above.Rw gmbh considers this matter closed.However, in the event rw gmbh receives any additional information, a follow-up report will be submitted to fda.Rwmic is submitting the report on behalf of rw gmbh.".

• Brand Name: INTRADISC FORCEPS Ø 5.2MM WL 244MM
• Type of Device: INTRADISC FORCEPS COLOR CODE WHITE, TL 393MM WITH IRRIGATION CONNECTION REUSABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 13903740
• MDR Text Key: 297901843
• Report Number: 9611102-2022-00012
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 04055207020753
• UDI-Public: 04055207020753
• Combination Product (y/n): N
• Reporter Country Code: AN
• PMA/PMN Number: K973405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8792623
• Device Catalogue Number: 8792623
• Device Lot Number: 1416228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1