MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM; APPLIANCE,FIXATION,NAIL

Model Number	292.71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-code: jey.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: 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 during fixation of the proximal humerus with an unknown plate and screws on an unknown date, the 1.6mm kirschner wire broke while it was used for temporary fixation.The broken piece was left inside the patient.The procedure was successfully completed without surgical delay.There was no patient consequence reported.Concomitant device reported: unknown plate (part # unknown, lot # unknown, quantity 1), unknown screws (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This report is 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.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 (b)(6) 2020, during fixation of the proximal humerus with an unknown plate and screws the 1.6mm kirschner wire broke while it was used for temporary fixation.The broken piece was left inside the patient.The surgeon fixed the fracture and out screws through the plate.He did not use another k wire.The procedure was successfully completed without surgical delay.There was no patient consequence reported.Concomitant device reported: plate (part number unknown, lot unknown, quantity 1), screws (part number unknown, lot unknown, quantity unknown).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10092104
• Report Number: 2939274-2020-02523
• Device Sequence Number: 17114036
• Product Code: KTT
• UDI-Device Identifier: 20886982180862
• UDI-Public: (01)20886982180862
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K971987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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: 292.71
• Device Catalogue Number: 292.71
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/05/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES; UNK - SCREWS: TRAUMA