MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM; WIRE, SURGICAL

Model Number 292.16

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Manufacturer Narrative

Additional procode: hty.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on an unknown date, the or/mdrd manager informed the sales consultant of a concern over the packaging of 10 pack k-wires.There have been three incidents in the past 6 months where a trocar point wire has come right through the packaging and injured an mdrd staff's hand.The incidents occurred after the restocking of the instrument tray during the reprocessing/sterilizing protocols.The most recent incident was more severe in that the wire went through the hand (previous incidents were only minor pricks/cuts).These incidents have all happened when only 1 or 2 wires are left in the pack and upon closing the pack, the wire has easily gone through the plastic.The sales consultant provided suggestions to avoid these incidents but there is a concern over the packaging and the staff believes the plastic feels more "flimsy" than in the past.This report is for a 1.6mm kirschner wire w/trocar point 150mm.This is report 1 of 1 for (b)(4) and captures the second incident.The first and third incidents are captured under (b)(4), respectively.

• Brand Name: 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11828952
• MDR Text Key: 250849877
• Report Number: 2939274-2021-02380
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 20886982180374
• UDI-Public: (01)20886982180374
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 292.16
• Device Catalogue Number: 292.16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention