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

Catalog Number 58-3200J-BD

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received for investigation with the screw intact.There appeared to be damage on the screw, however, it is unknown if the damage occurred when the screw was placed back in the device or if it had been taken apart at the facility.This customer also returned another rongeur for an issue of sticking, this device also showed damage on the screw.Based on this information, it can be determined that the end user is removing the screws for cleaning.The screws of these devices are not intended to be removed, they are ping welded by the supplier to help prevent them from backing out during use.Once this weld is broken by removal at the user facility, it can back out during use.There have been 4 total complaints recorded for screws coming out of 58-3200j-bd and 58-3200-bd since 2012.In all cases the screws showed damage indicative of being removed at the user facility.There has been a total of (b)(4) sold 58-3200j-bd.There has been a total of (b)(4) sold of 58-3200-bd.This can be seen as the final report, if additional information is obtained that alleges additional patient involvement or the need for corrective actions, a follow up report will be submitted.

Event Description

The kerrison fell apart during a case.The screw came out and fell into the open wound.The screw was retrieved and there was no harm to the patient.

• Brand Name: SYMMETRY RAPIDCLEAN
• Type of Device: KERRISON RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch, tn
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen drive; antioch, tn
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, tn ; 9645290
• MDR Report Key: 9875645
• MDR Text Key: 199280384
• Report Number: 3007208013-2020-00007
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• 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: 03/10/2020
• Date Manufacturer Received: 02/28/2020
• 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