MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY; CURETTE

Catalog Number	61-0380
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The part is being returned for evaluation but has not been received yet.There has been a total of (b)(4) sold of this product since 2012 with no additional complaints recorded.A follow up report will be submitted once the product is evaluated.
Event or Problem Description
The customer alleged that during the procedure, the surgeon was drilling with a midas rex drill.Post drilling, the curette was being used in the area when it sheared.A piece of the currette fell into the patient.The piece was removed with no further affect on the patient.
Additional Manufacturer Narrative
Per the lot number on the device, this item was sold to the distribution center in (b)(6) 2018.It is unknown when the distributor sold the device to the end user.The returned device was checked for proper material and hardness.Both readings were found to be within conformance per the product specifications and intended use.Upon evaluating the returned instrument the small curette end was confirmed to be broken off.The piece that broke off was not returned with the device.There appeared to be signs of stress around the break that is indicitive of excessive force on the device.It can be determined from the evaluation that the damage was most likely the result of use not per the intended use of the device.This is an isolated event and no further actions are required.This can be seen as a the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions a follow up report will be submitted.

• Brand Name: SYMMETRY
• Common Device Name: CURETTE
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 10985144
• Report Number: 3007208013-2020-00037
• Device Sequence Number: 3595135
• Product Code: HTF
• UDI-Device Identifier: 00887482113875
• UDI-Public: 00887482113875
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 61-0380
• Device Lot Number: 040217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1