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

Catalog Number 50-4582

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 321934523
• Report Number: 3007208013-2023-00037
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 00887482018545
• UDI-Public: 00887482018545
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-4582
• Device Lot Number: R002S467/28
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1