MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6 KIRSCHNER WIRE W/TRCR POINT 150-10PK; PIN, FIXATION, SMOOTH

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 device product code: lrn.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j 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 synthes reports an event in (b)(6) as follows: it was reported that there was a concern over the packaging of 10 pack k-wires.There have been 3 incidents in the past 6 months where a trocar point wire has come right through the packaging and injured an mdrd staff's hand.In the most recent incident 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 plastic feels more "flimsy" than in the past.The incidents occurred after the restocking of the instrument tray during reprocessing/sterilizing protocols.This report is for one (1) 1.6mm kirschner wire w/trocar point 150mm.This is report 1 of 1 for (b)(4).

Event Description

(b)(4) captures the first incident.The second and third incidents are captured under (b)(4) and (b)(4), respectively.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: 1.6 KIRSCHNER WIRE W/TRCR POINT 150-10PK
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11825774
• MDR Text Key: 250656559
• Report Number: 2939274-2021-02373
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 20886982180374
• UDI-Public: (01)20886982180374
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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: Health Professional
• Device Model Number: 292.16
• Device Catalogue Number: 292.16
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/15/2021
• Supplement Dates FDA Received: 06/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention