MAUDE Adverse Event Report: SYMMETRY SURGICAL INC BOOKWALTER; RETRACTOR

Catalog Number	50-4696
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is being returned for evaluation.There has been a total of 20,600 sold of all lots with 4 additional complaints for similar occurrences (0.0048%) - low complaint rate.Once the device has been evaluated, a follow up report will be submitted.
Event or Problem Description
The customer alleged that the bookwalter ratchet is falling apart during the procedrue in the operating room.There is no harm to the patient.
Additional Manufacturer Narrative
Corrections: customer notified us on 8/9/2023 that the affected part number was actually 50-4696 instead of the original report for 50-4580.As a reslut, the gtin number was corrected as well.The returned device was 50-4696 with a date code 191.The date code indicates that the device was manufactured in 2019 and therefore has been in use for approximately 4 years.The evaluation of the returned device, noted significant wear and tear on the device and confirmed that a screw is missing.The screw was not returned with the device.The screw hole shows evidence of the original weld location confirming that the screw was properly secured during manufacturing.Without the screw, a true root cause cannot be determined regarding the failure.However, the device has been in use for approximately 4 years before the failure occurred.There has been a total of (b)(4) sold of all lots with 3 additional complaints recorded for a similar occurrence.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 informaiton pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: BOOKWALTER
• Common Device Name: 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: 17442365
• Report Number: 3007208013-2023-00035
• Device Sequence Number: 2531622
• Product Code: GAD
• UDI-Device Identifier: 00887482034064
• UDI-Public: 00887482034064
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Followup
• Report Date (Section B): 08/23/2023

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
• Device Catalogue Number: 50-4696
• Device Lot Number: 191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2019
• 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