MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY SURGICAL INC.; SCISSORS

Model Number	60-1868
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
The complainant alleges, "two of the scissors had screws fall out during the case.They had to take x-rays and thankfully neither of the screws ended up in the patient.".
Additional Manufacturer Narrative
Awaiting additional information and/or return of the reported device to complete the evaluation.
Additional Manufacturer Narrative
The returned product with missing screws and additional items from the same lot were returned to the supplier on 6/4/2024.Upon the supplier's investigation of the returned devices: device history record (dhr) was retrieved and reviewed by qa & ra department after getting complaint notification from symmetry/aspen.All manufacturing processes and intermediate inspection were performed.The non-conforming returned instruments were physically evaluated and 2 instruments out of 15 instruments were found unscrewed while only 1 instrument out of remaining 13 instruments was found with loose screw during screw torque inspection.Moreover, 12 instrument's screw torque was checked and they were found to be ok.After review of device history record (dhr) and evaluation of non-conforming returned instruments, the potential reason which could lead to this non-conformity appears to be excessive belt grinding at the lower part of the box lock area on the 2 unscrewed instruments leaving less space for threads of screw to be threaded/grip properly.The root cause is determined to be manufacturing error.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, "two of the scissors had screws fall out during the case.They had to take x-rays and thankfully neither of the screws ended up in the patient.".

• Brand Name: SYMMETRY SURGICAL INC.
• Common Device Name: SCISSORS
• 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: 19243737
• Report Number: 3007208013-2024-00016
• Device Sequence Number: 6949133
• Product Code: LRW
• UDI-Device Identifier: 00887482110782
• UDI-Public: 00887482110782
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 60-1868
• Device Lot Number: 2312314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown