MAUDE Adverse Event Report: SYMMETRY SURGICAL INC CODMAN; METZENBAUM SCISSORS

Catalog Number	36-5033
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that during the first few minutes of the pthe surgery, the scissor was being cleaned off and it was noticed that the tip was broken off.The doctor and resident was notified and the area was searched to try and locate it and it was not found.An x-ray was called, and the piece was not found inside the patient.Most likely, the piece was suctioned up by irrigation.There was no harm to the patient.
Additional Manufacturer Narrative
This report is response to the user facility report# (b)(4).The device was not available for return.Pictures were provided of the damage, however additional pictures of the device to determine date code or lot number were not available.The codman logo was present on the device, which indicates that the device was purchase through codman or shortly after the acquisition of the company.Symmetry surgical acquired codman in q4 of 2012.Therefore the device has been in use for at least 10 years.Without the device itself or a confirmation of the lot number a true root cause cannot be determined.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: CODMAN
• Common Device Name: METZENBAUM SCISSORS
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 17419514
• Report Number: 3007208013-2023-00034
• Device Sequence Number: 8902202
• Product Code: LRW
• UDI-Device Identifier: 00887482010259
• UDI-Public: 00887482010259
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 36-5033
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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