MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY CLAMP, DIETHRICH BULLDOG, ANGLED, 12 MM; DIETHRICH BULLDOG CLAMP

Model Number	19-8091
Medical Device Problem Codes	Failure to Align (2522); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is in process of being returned for evaluation.The investigation is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "the clamps are not holding vessels effectively and bleeding does not stop upon application, which is a matter of serious concern during surgeries.".
Additional Manufacturer Narrative
The devices were attempted to be returned, but they were lost during the return process.No pictures were provided.The complaint could not be confirmed, and root cause is undetermined.Initially when this was reported to us, it indicated that the device failed during use, making it reportable.We reviewed similar lots and devices in our inventory, and all tested out in specification and showed no concerns.However, we have received additional information now, indicating that the devices were never actually used.When they stated "the clamps are not holding vessels effectively and bleeding does not stop upon application", we believed that the device was actually used in a procedure and had that outcome.However, when asked additional questions, they stated that the device was not used in a procedure, the "problem" was discovered during their testing.Therefore this complaint is not reportable.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: SYMMETRY CLAMP, DIETHRICH BULLDOG, ANGLED, 12 MM
• Common Device Name: DIETHRICH BULLDOG CLAMP
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: terry hall ; 3034 owen drive; antioch, TN 37013 ; 6166987100
• MDR Report Key: 22646699
• Report Number: 3007208013-2025-00038
• Device Sequence Number: 8609836
• Product Code: DXC
• UDI-Device Identifier: 00887482000786
• UDI-Public: 00887482000786
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K982365
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: 19-8091
• Device Lot Number: 10050686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown