MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY SAW, GIGLI WIRE, 20 IN, 508 MM; GIGLI SAW WIRE

Model Number	75-1004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation.The investigation is ongoing.Once additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "we are receiving complaints from various hospitals with regard to giglisaw wire getting broken easily while cutting the bone during procedures.".
Additional Manufacturer Narrative
The devices were returned for evaluation, and the complaint was confirmed.Per the product label, the devices are indicated for single use.As part of the complaint intake it was stated that the devices have been in use since 2020, indicating the end users are re-using the devices which is considered off-label use.The product was not designed for multiple uses and multiple sterilization cycles which have the potential to impact the strength of the loops that attach to the handles.The root cause is user customer misuse.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: SYMMETRY SAW, GIGLI WIRE, 20 IN, 508 MM
• Common Device Name: GIGLI SAW WIRE
• 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: 23645376
• Report Number: 3007208013-2025-00060
• Device Sequence Number: 21289387
• Product Code: GFA
• UDI-Device Identifier: 00887482030103
• UDI-Public: 00887482030103
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: 75-1004
• Device Lot Number: R003S399/98
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown