MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY FORCEPS, BALLENTINE HYSTERECTOMY, 8 1/2; SURGICAL FORCEPS

Model Number	30-5801
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot number was given.We are attempting to get more information about the product, including returning the product for evaluation and/or obtaining pictures.The investigation is ongoing, and the quality of the investigation will be determined by what additional information we can obtain.If additional information is obtained that is pertinent to the investigation or provides additional details, a follow-up report will be provided.Until such time, this can be seen as the final report.
Event or Problem Description
The complainant alleges, "during an abdominal hysterctomy, a straight heaney instrument tip broke off inside the patient.Two pieces broke.Both pieces accounted for and verified by both surgeons performing procedures.".
Additional Manufacturer Narrative
Based on information provided from the customer (b)(6) lot 9612 is stamped on the instrument.This information indicates that the device was manufactured in december 1996 and has therefore been in use for approximately 28 years prior to the damage occurring.Root cause : wear and tear over many years of use.If additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.Until such time, this can be seen as the final report.
Event or Problem Description
The complainant alleges, "during an abdominal hysterectomy, a straight heaney instrument tip broke off inside the patient.Two pieces broke.Both pieces accounted for and verified by both surgeons performing procedures.".

• Brand Name: SYMMETRY FORCEPS, BALLENTINE HYSTERECTOMY, 8 1/2
• Common Device Name: SURGICAL FORCEPS
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 20100076
• Report Number: 3007208013-2024-00043
• Device Sequence Number: 20770536
• Product Code: HCZ
• UDI-Device Identifier: 00887482004746
• UDI-Public: 00887482004746
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: 30-5801
• Device Lot Number: 9612
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/27/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female