MAUDE Adverse Event Report: RICHARD WOLF GMBH S-LINE; WORKING ELEMENT ACTIVE BIPO 0/12/30

Model Number	8680205
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the handle on the work element is bent, which means the hf sling cannot be moved all the way to the end.The operation could not be completed.The working element active bipo 0/12/30° batch 1486209 was inspected by our specialist department and it was found that the arms are severely bent, meaning that the full stroke of the working element is no longer available.The cause is due to severe mechanical overload.In our view, the operating instructions ga-d342 (in chapters 7, 8 and 9) contain sufficient information for the visual and functional check.The operating instructions refer to the checks to be performed at several points.In the risk assessment b6 r02, possible risks were considered with the corresponding extent of damage and the assumed probability of occurrence and assessed as an acceptable risk.This assessment remains valid even in the light of the current case.Both the production records and the complaints database for the work item have been checked.The records do not indicate any production or batch defects.
Event or Problem Description
The customer stated that the handle on the workpiece is bent, preventing the hf loop from being moved all the way to the end.The surgery could not be completed.The user did not provide any information regarding the patient's condition.

• Brand Name: S-LINE
• Common Device Name: WORKING ELEMENT ACTIVE BIPO 0/12/30
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• 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: 24821595
• Report Number: 9611102-2026-00011
• Device Sequence Number: 9630948
• Product Code: FDC
• UDI-Device Identifier: 04055207042939
• UDI-Public: 04055207042939
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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
• Device Model Number: 8680205
• Device Catalogue Number: 8680.205
• Device Lot Number: 1486209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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