MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.8MM KIRSCHNER WIRE WITH TROCAR POINT 150MM; PIN,FIXATION,SMOOTH

Model Number	02.110.300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent an open reduction internal fixation (orif) in the patella due to an unknown reason.A kirschner wire was broken while being used to reduced the fractured patella.The kirschner wire broke where the compression of the wire driver met the wire.It was mentioned that visible smoke was seen before the kirschner wire broke and believed that it was not being held by the wire driver correctly leading to the failure of the wire.The kirschner wire was removed from patella and was disposed in the sharp bin.A new wire was used.There were no pieces left in the patient as it was not broken at the site of the patella.There was no surgical delay.Procedure was successfully completed with no patient consequence.This report is for one (1) 1.8mm kirschner wire with trocar point 150mm.This is report 1 of 1 for (b)(4).
Additional 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.H10 additional narrative: additional data- b5, d11 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 or Problem Description
Concomitant device reported: unk - power wire driver (part# unknown, lot# unknown, quantity# 1).

• Brand Name: 1.8MM KIRSCHNER WIRE WITH TROCAR POINT 150MM
• Common Device Name: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8353667
• Report Number: 2939274-2019-56542
• Device Sequence Number: 19234027
• Product Code: HTY
• UDI-Device Identifier: 20886982030617
• UDI-Public: (01)20886982030617
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.110.300
• Device Catalogue Number: 02.110.300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE EVENT DESCRIPTION.