MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. CLASSIC PLUS NEEDLE HOLDER CRILE-WOOD, 6 IN

Model Number	36-2000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "we had an issue with one of the crilewood needle holders that we just ordered.The insert chipped off while the surgeon was using it.".
Additional Manufacturer Narrative
The actual device has been returned and evaluated.The investigation is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The actual devices were returned for evaluation.They were only in use for a short period of time, as the customer had the product less than a month before the incident occurred.At some point during either transit, material handling, or reprocessing, the instruments may have been dropped with the tip-first, leading to structural deformation.The impact may have compromised the integrity of the product, thereby causing the breakage of the tip inserts.The root cause is transit damage.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: CLASSIC PLUS NEEDLE HOLDER CRILE-WOOD, 6 IN
• Common Device Name: NEEDLE HOLDER
• 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: 22107350
• Report Number: 3007208013-2025-00013
• Device Sequence Number: 20652086
• Product Code: HXK
• UDI-Device Identifier: 00887482009628
• UDI-Public: 00887482009628
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/18/2025

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: 36-2000
• Device Lot Number: 31082242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown