MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY DIETHRICH; SCISSORS

Catalog Number	32-844
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was purchased (b)(6) 2017 and had approximately 1.5 years of use.Upon receiving the returned device, the hardness and material of the device were evaluated.It was determined that the device was within specifications.Upon further evaluation of the device, it was noticed that the cutting edges were scratched and chipped in some place.This type of damage is consistent with damage that would occur if the scissor was used in a way not intended for the purpose of the device.This particular device has an extremely delicate scissor tip that can easily become broken if used incorrectly.This is the only complaint recorded for this device with (b)(4) sold.This report can be seen as the final report.If additional information is received that alleges any additional patient involvement or a need for corrective actions a follow-up report will be submitted.
Event or Problem Description
The tip of the diethrich scissor broke off.It was noticed that the tip was broken in reprocessing.As a result the patient had to be recalled and an investigation was carried out to determine if the piece remained in the patient.It was communicated that the patient was not impacted by the broken tip.

• Brand Name: SYMMETRY DIETHRICH
• Common Device Name: SCISSORS
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 8274807
• Report Number: 3007208013-2019-00003
• Device Sequence Number: 159064
• Product Code: LRW
• UDI-Device Identifier: 00887482071670
• UDI-Public: 00887482071670
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2019

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: Health Professional
• Device Catalogue Number: 32-844
• Device Lot Number: 110216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1