MAUDE Adverse Event Report: SYMMETRY SURGICAL INC BOOKWALTER; RATCHET RETRACTOR

Model Number	50-4580
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved was discarded at the facility and cannot be returned for evaluation.Pictures are not available and the lot number is unknown.Without the lot number the age of the device is unknown.The customer is unsure when the screw fell out of the device.Received via fda user facility report# 2600320000-2023-8082.There has been a total of (b)(4) sold of all lots with 1 additional complaint recorded for 8 instruments (b)(4).The previous complaint for 8 instruments were all aged devices that had significant signs of use.Based on the information that we have received thus far, 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 follow up report will be submitted.
Event or Problem Description
The customer alleged that during a pancreatic transplant, the clip of the bookwalter ratchet would not secure properly to the ring.Upon further inspection of the ratchet, it was noticed that a small screw was missing.This occurred at the first use of the device during the procedure, so it is unknown if the screw fell out during that procedure or previously.There was no affect on the patient.

• Brand Name: BOOKWALTER
• Common Device Name: RATCHET RETRACTOR
• 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: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 17148576
• Report Number: 3007208013-2023-00024
• Device Sequence Number: 5589898
• Product Code: GAD
• UDI-Device Identifier: 00887482018545
• UDI-Public: 00887482018545
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 50-4580
• Device Catalogue Number: 50-4580
• 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: 05/23/2023
• Initial Report FDA Received Date: 06/16/2023
• 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