MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM; BONE PLATE

Model Number	292.71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is patient's relative.(b)(4).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
It was reported that on an unknown date of 2010, a patient underwent a surgery due to a left patellar fracture.Patient's hardware which was a 1.6mm k-wire and 2.0mm k-wire were broken postoperatively.Another surgery was done on an unknown date.No further information is provided.This report is for one (1)1.6mm kirschner wire with 5mm thread-trocar point 150mm this is report 1 of 2 for complaint (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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.H3, h4, h6: 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.

• Brand Name: 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9781042
• Report Number: 2939274-2020-01111
• Device Sequence Number: 13625167
• Product Code: JEY
• UDI-Device Identifier: 20886982180862
• UDI-Public: (01)20886982180862
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K971987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 292.71
• Device Catalogue Number: 292.71
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention