MAUDE Adverse Event Report: RICHARD WOLF GMBH VERTEBRIS; PUNCH Ø 5.4MM WL 340MM

Model Number	892409020
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility has informed richard wolf gmbh an issue regarding a punch ø 5.4 mm wl 340 mm, part id: 892409020, lot # 4500355424.According to the received information, "when the product comes out of the bow, a piece remains in the nurse's hand.The tip comes off.No risk to the patient." additionally, this case was reported by the customer to the french national agency for the safety of medicines and health products (ansm).
Additional Manufacturer Narrative
During the inspection in the specialized department it was found that the head guide from the outer pipe is loose.The cause is due to welding not made deep enough.The punch ø 5.4 mm wl 340 mm, part id: 892409020 originates from the batch 4500355424 and was booked to the new goods warehouse on 02/may/2022.Apparently, no deviation was found during the incoming inspection.The delivery to the customer from this batch, took place on (b)(6), 2022.In general, the user is advised in the associated instructions for use ga-b251/ en/ eu/v1.0/ 2021-04 under chapter 9 that a visual and functional check must be carried out before and after each use.Possible damage of the above type can be easily detected by hospital staff if these instructions are followed.No comparable case, this type 892409020 is registered in the period under consideration.In our risk analysis b1-2 rev.05, 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: VERTEBRIS
• Common Device Name: PUNCH Ø 5.4MM WL 340MM
• 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: 17309594
• Report Number: 9611102-2023-00045
• Device Sequence Number: 7261025
• Product Code: NBH
• UDI-Device Identifier: 04055207046913
• UDI-Public: 04055207046913
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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
• Device Model Number: 892409020
• Device Catalogue Number: 892409020
• Device Lot Number: 4500355424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown