MAUDE Adverse Event Report: SYMMETRY SURGICAL INC RAPIDCLEAN KERRISON RONGEUR

Model Number 53-1624LD

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Information (3190)

Event Date 08/31/2018

Event Type  malfunction  

Event Description

The pin fell out of the instrument, this came to their attention when the surgeon noticed the pin laying on the sterile drape next to the site.

Manufacturer Narrative

Corrected part number and lot number to p/n 53-1627 led lot# 20141951 instrument was purchased 5/19/17 on order #407105.Customer originally reported the incorrect part number for this complaint ((b)(4)).Upon receipt of the instrument on 10/4/2018, it was determined that it was actually part #53-1627 led that was missing a pin.The broken pin was not returned with the instrument, so root cause cannot be determined.There was no damage to the pin holes, however, there was noticeable scratches/tool marking on the underside of the lock.This is an isolated incident with no other complaints reported for this issue.This can be seen as the final report.If additional information is obtained that alleges the need for corrective actions or indicates a risk to patient safety, a follow-up report will be submitted.

• Brand Name: RAPIDCLEAN KERRISON RONGEUR
• Type of Device: RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7905832
• MDR Text Key: 121861128
• Report Number: 3007208013-2018-00007
• Device Sequence Number: 1
• Product Code: HAE
• UDI-Device Identifier: 00887482034521
• UDI-Public: 00887482034521
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 53-1624LD
• Device Catalogue Number: 53-1627LED
• Device Lot Number: 20141951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Distributor Facility Aware Date: 10/04/2018
• Device Age: 1 YR
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1