MAUDE Adverse Event Report: ARTHREX, INC. BONE REDUCTION FORCEPS, CURVED, POINTED

Model Number	BONE REDUCTION FORCEPS, CURVED, POINTED
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/21/2025, a facility representative reported via (b)(4) that (qty.2) ar-8943-07 curved, pointed bone reduction forceps were bent at the tips and not where they were supposed to be.They were discovered during a case, but no patient was affected.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that both tips of the bone reduction forceps, curved, pointed had bent.Laser markings were rusted and faded.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user-applied excessive mechanical forces.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8943-07 was received for investigation.Upon visual inspection, it was noted that both tips of the bone reduction forceps, curved, pointed had bent.Laser markings were rusted and faded.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user-applied excessive mechanical forces.Refer to investigation photos.Complaint allegation is confirmed.

• Brand Name: BONE REDUCTION FORCEPS, CURVED, POINTED
• Common Device Name: FORCEPS
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22029757
• Report Number: 1220246-2025-02065
• Device Sequence Number: 18178193
• Product Code: MDM
• UDI-Device Identifier: 00841435116887
• UDI-Public: (01)00841435116887(11)240319(10)672345
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: BONE REDUCTION FORCEPS, CURVED, POINTED
• Device Catalogue Number: AR-8943-07
• Device Lot Number: 672345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 04/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 09/05/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/18/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown