MAUDE Adverse Event Report: SYMMETRY SURGICAL INC CLASSIC PLUS; NEEDLE HOLDER

Model Number	36-2002
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported product: 36-2002.Description: classic plus® needle holder, crile-wood, 8 in.Dear valued customer, symmetry surgical is providing this summary in response to the incident involving the crile-wood needle holder.We apologize for any inconvenience this issue may have caused.The quality assurance investigation is complete with the following results: unfortunately, the needle holder was unable to be returned for a physical evaluation.A remote evaluation was accomplished using pictures provided of the broken instrument.Pictures showed that a piece of the tungsten carbide insert broke off the needle holder and that the instrument had been etched with a may 2018 repair code.Since the lot number was polished off we were unable to determine the exact date the instrument was purchased.We sent all pictures and information to our repair facility, five star, for investigation.They confirmed that the repair code etched on the instrument was theirs.Through their assessment they determined that the insert did not fail due to poor workmanship but likely failed due to a small hair line crack in the insert.The small hair line crack likely occurred due to excessive force or impact to the insert region, therefore weakening the insert and causing it to partially break off in the manner depicted in the photos.Thank you for your patience during the investigation of this issue.If you have any questions or concerns, please feel free to contact me.(b)(4).
Event or Problem Description
Needle holder (refurbished in may 2018) tungsten carbide insert broke off during a case and is currently retrained in the patient, confirmed by chest x-ray.

• Brand Name: CLASSIC PLUS
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7844472
• Report Number: 3007208013-2018-00019
• Device Sequence Number: 1445782
• Product Code: HXK
• UDI-Device Identifier: 00887482009642
• UDI-Public: 00887482009642
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

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: 36-2002
• Device Catalogue Number: 36-2002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1