MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY RAPIDCLEAN; KERRISON RONGUER

Catalog Number 58-3200J-BD

Device Problem Material Separation (1562)

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

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation.We have completed our initial evaluation of the device, however we are waiting for final paperwork on the device to complete the investigation.There has been a total of (b)(4) sold of all lots of this part number since 2012.There has been a total of 3 additional complaints recorded for similar occurrences.Two of which occurred in february and august of 2020 from the same customer.The one additional complaint was recorded in 2015 and was found to be the result of the hospital tampering with the screws.A final report will be submitted once we have all of the paperwork and information necessary.

Event Description

The screw came out of the kerrison during the procedure and fell into the patient.The screw was retrieved with no harm to the patient.

• Brand Name: SYMMETRY RAPIDCLEAN
• Type of Device: KERRISON RONGUER
• 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: 10775096
• MDR Text Key: 220757188
• Report Number: 3007208013-2020-00031
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00887482102527
• UDI-Public: 00887482102527
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 58-3200J-BD
• Device Lot Number: T01-81802648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1