MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY BOOKWALTER; HORIZONTAL FLEX BAR

Catalog Number	50-4582
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the purchase date provided by the customer, the device has been in use for approximately 4 years.Additionally, the customer notified us that the device is being regularly lubricated.The instructions for use of this device has a warning stating that this device should not be lubricated as it could cause movement during use.Over many years of use and lubrications, the lubricant will begin to build up within the locking mechanism which could prevent it from locking properly.The customer was notified of the proper way to care for the device and it was recommended that the device be refurbished.(b)(4).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.
Event or Problem Description
The customer alleged that the bookwalter horizontal flex bar became loose causing it to fall into the patient's abdomen.There was no harm to the patient.A delay in the procedure occurred to correct the placement of the devices.The length of the delay is unknown.

• Brand Name: SYMMETRY BOOKWALTER
• Common Device Name: HORIZONTAL FLEX BAR
• 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: 17596456
• Report Number: 3007208013-2023-00037
• Device Sequence Number: 20466776
• Product Code: GAD
• UDI-Device Identifier: 00887482018545
• UDI-Public: 00887482018545
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2023

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 Catalogue Number: 50-4582
• Device Lot Number: R002S467/28
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (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