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

Catalog Number 71210003

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2018

Event Type  Injury  

Event 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.

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
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull hu3 2bn; UK
• MDR Report Key: 7489384
• MDR Text Key: 107438149
• Report Number: 1020279-2018-00869
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 03596010185747
• UDI-Public: 03596010185747
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120871
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Nurse
• Device Catalogue Number: 71210003
• Device Lot Number: 16FNX0040A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/05/2018
• Supplement Dates Manufacturer Received: 04/18/2018
• Supplement Dates FDA Received: 07/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1