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

Model Number	848804
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility representative has informed richard wolf gmbh an issue regarding hook scissors ø 3.4mm, part no.848804 with lot no.1466617.According to the received information: "when the biceps tendon was cut, the pins of the scissors jaw were broken.The broken jaws could not be retrieved out of the shoulder joint because they could not be located.X-ray was made and it is available.Remaining part of the device (without jaw parts) was returned to richard wolf gmbh for further investigation".
Event or Problem Description
According to the new received information, it could not be clarified which circumstances have led to that the missing broken parts of the device could not be recovered.
Additional Manufacturer Narrative
The hook scissors ø 3.4mm 848804, batch # 1466617 was investigated in the responsible department.It was determined that the non-movable scissor blade broke off at the transition to the 3.4mm diameter.As a result, the movable scissor blade could also became loose.A material hardness test was carried out at the point of the breakage.The measured values meet the specifications.In conclusion, excessive use of force caused the scissor blades to break off.The hook scissors ø 3.4mm 848804, batch # 1466617 was manufactured on 04/feb/2021.The batch consisted of 11 pieces.No issue was identified during production and no further complaints were received from the reported batch.The ifu ga-s 003 / usa / 2013-06 v2.0 / eco 2013-0159 contains several safety instructions and notes regarding the issue of using excessive force on the device in section 6 use.Furthermore, the user is advised to check the device prior and after each use in section 7 checks.The subject issue of breakage and part loss is present in the risk management file b1-2: reusable non-optical forceps and scissors, rev.: r05.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: NA
• 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: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16559511
• Report Number: 9611102-2023-00016
• Device Sequence Number: 14878986
• Product Code: HRR
• UDI-Device Identifier: 04055207010525
• UDI-Public: 04055207010525
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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: 848804
• Device Catalogue Number: 8488.04
• Device Lot Number: 1466617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown