MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM SCHANZ SCREW SPADE POINT 190MM/HA COATING-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	294.68SHA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 (b)(6) 2019, the patient underwent revision of maxframe to replace broken schanz pin.The pin was broken at the thread shaft junction.The schanz pin was partially removed.The deep buried part of the broken pin was not attempted to be removed and remains in the patient.The surgeon elected not to go after the broken short segment of the pin that remains in the bone.Several new schanz pin were put in to replace the broken one.There was no surgical delay.Procedure was successfully completed.Patient was stable.Concomitant device reported: unknown maxframe (part # unknown, lot # unknown, quantity # 1).This report is for one (1) 6.0mm schanz screw spade point 190mm/ha coating-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 6.0MM SCHANZ SCREW SPADE POINT 190MM/HA COATING-STERILE
• 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: 8712116
• Report Number: 2939274-2019-58743
• Device Sequence Number: 2286390
• Product Code: KTT
• UDI-Device Identifier: 10886982181664
• UDI-Public: (01)10886982181664
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K122455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2019

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: 294.68SHA
• Device Catalogue Number: 294.68SHA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/19/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - MAXFRAME
• Outcome Attributed to Adverse Event: Required Intervention