MAUDE Adverse Event Report: ARTHREX, INC. REDUCTION CLAMP; ORTHOPEDIC MANUAL SURG INSTR

Model Number	REDUCTION CLAMP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 6/4/2024 a sales representative reported via (b)(4) that an ar-8841rc reduction clamp broke during a case, with no affect on the patient or the outcome of the case.This was discovered during a procedure, with no reported patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-8841rc, guide broach, batch 1068582322, was received for investigation.Visual evaluation noted that the that the hinge pin was loose.Additionally, both of the sleeves appear to have damage to the geometry of the device.Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure can be attributed to excessive user-applied mechanical forces.

• Brand Name: REDUCTION CLAMP
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19643108
• Report Number: 1220246-2024-06519
• Device Sequence Number: 7118968
• Product Code: LXH
• UDI-Device Identifier: 00888867441378
• UDI-Public: 00888867441378
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: REDUCTION CLAMP
• Device Catalogue Number: AR-8841RC
• Device Lot Number: 1068582322
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown