MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS AND ECLIPSE HEAD IMPACTOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS AND ECLIPSE HEAD IMPACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
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 06/13/2024 it was reported by a sales representative via (b)(4) that an ar-9202-13 impactor handle was broken.This was discovered during a procedure with no patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-9202-13, head impactor, serial/batch number (b)(6), was received for investigation.Visual inspection noted that the handle is cracked along a pin on the handle.Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure can be attributed to misuse due to excessive user-applied mechanical forces.

• Brand Name: UNIVERS AND ECLIPSE HEAD IMPACTOR
• 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: 19700390
• Report Number: 1220246-2024-06654
• Device Sequence Number: 19743104
• Product Code: LXH
• UDI-Device Identifier: 00888867058378
• UDI-Public: 00888867058378
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/20/2024

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: UNIVERS AND ECLIPSE HEAD IMPACTOR
• Device Catalogue Number: AR-9202-13
• Device Lot Number: 052109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown