MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS TROCAR PIN 1/8 IN. X {} 5IN; PIN, FIXATION, THREADED

Catalog Number	71210003
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Box of pins was opened to reveal one pin had pierced plastic protective end and through plastic package as well.Scrub nurse was pricked by exposed sharp end.
Additional Manufacturer Narrative
The associated complaint devices and packaging were returned and evaluated.A visual examination of the returned trocar pins and packaging confirmed that stated complaint.One of the pins punctured the protect covering.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated that several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of complaint history on the listed part revealed no prior complaints for the listed batch.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GNS TROCAR PIN 1/8 IN. X {} 5IN
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7489384
• Report Number: 1020279-2018-00869
• Device Sequence Number: 145103
• Product Code: JDW
• UDI-Device Identifier: 03596010185747
• UDI-Public: 03596010185747
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2018

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: Nurse
• Device Catalogue Number: 71210003
• Device Lot Number: 16FNX0040A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/05/2018
• Supplement Report FDA Received Date: 07/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1