MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. SYMMETRY; TENACULUM FORCEP

Model Number	90-1008
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device broke during a procedure while inside the trocar.
Additional Manufacturer Narrative
Paper copy report was mailed to the office on 29feb2024.Tracking number is (b)(4).This mail was received by (b)(6).

• Brand Name: SYMMETRY
• Common Device Name: TENACULUM FORCEP
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.
• Manufacturer Contact: asmita patel ; 626 cooper ct; 8479086121
• MDR Report Key: 18872156
• Report Number: 1421101-2024-00002
• Device Sequence Number: 11524962
• Product Code: GEI
• UDI-Device Identifier: 00887482128510
• UDI-Public: 00887482128510
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K040855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

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
• Device Model Number: 90-1008
• Device Lot Number: 110221
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2024
• Date Device Manufactured: 11/24/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown