MAUDE Adverse Event Report: SYMMETRY SURGICAL INC RAPIDCLEAN KERRISON RONGEUR

Model Number	53-1624LD
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7905832
• Report Number: 3007208013-2018-00007
• Device Sequence Number: 1499799
• Product Code: HAE
• UDI-Device Identifier: 00887482034521
• UDI-Public: 00887482034521
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1