MAUDE Adverse Event Report: RICHARD WOLF GMBH; HOOK SCISSORS Ø 3.4MM

Model Number	8488041
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Instrument has not yet been sent for examination by the user.As soon as the instrument is in house, the examination will be started.So far, there has been no comparable case of this type.
Event or Problem Description
The user facility has informed richard wolf gmbh of an issue regarding a hook scissors ø 3.4mm, part id: 8488041, lot # unknown.According to the received information from the customer, le dr ruh, "report intraoperative breakage of a pair of arthroscopic scissors with loss of part of the instrument in the joint." the reporter claimed that the presence of the metallic element in the joint is a contraindication for an mr/examination.Therefore, the possibility of recovering the exogenous element is impossible.The patient outcome is negative and the long term consequences is unknown.This case was reported by the customer to the french national agency for the safety of medicines and health products (ansm).

• Common Device Name: HOOK SCISSORS Ø 3.4MM
• 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: 17406295
• Report Number: 9611102-2023-00050
• Device Sequence Number: 5962553
• Product Code: HRR
• UDI-Device Identifier: 04055207017760
• UDI-Public: 04055207017760
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2023

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: Health Professional
• Device Model Number: 8488041
• Device Catalogue Number: 8488.041
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown