MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN TROCAR PIN 1/8 X 3; PIN, FIXATION, THREADED

Catalog Number	71210002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while trying to open the package, the nurse was pricked by one of the pins.She had minor bleeding and was able to continue with the procedure.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation as conducted and insufficient information was provided to perform a thorough medical investigation therefore a root cause cannot be concluded.The nurse impact was the reported minor bleeding from the trochar pin-prick, however, required no medical intervention and was able to continue with the procedure.The patient impact was reportedly a minor 10 minute surgical delay without procedure deviation.No further harm or impact is expected due to the reported event.No further medical assessment is warranted at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GEN TROCAR PIN 1/8 X 3
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7454291
• Report Number: 1020279-2018-00805
• Device Sequence Number: 959641
• Product Code: JDW
• UDI-Device Identifier: 03596010185730
• UDI-Public: 03596010185730
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71210002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 04/24/2018; 04/24/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 04/30/2018; 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other