MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SELF-TAPPING 18MM; SCREW, FIXATION, BONE

Model Number	202.818
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes: dzl, ktw.Device broke intra-operatively; device is not considered implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4): the screw broke during insertion.The head of the screw was removed easily, however additional instrumentation was used to remove the shaft from the bone.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.
Event or Problem Description
It was reported that a patient underwent a tibia shaft surgery on (b)(6) 2018.During the procedure, a cortex screw head broke off during final tightening due to patients hard bone.Broken fragments were removed using a screw removal set on the screw shaft with trephine and a conical removal tools.A locking compression dynamic compression plate was selected as provision fixation prior to intramedullary nailing.There was no surgical delay reported.The procedure was successfully completed.The patient outcome was as planned.Concomitant device reported: locking compression dynamic compression plate (part # 242.206, lot # unknown, quantity # 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 2.7MM CORTEX SCREW SELF-TAPPING 18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8173619
• Report Number: 2939274-2018-55438
• Device Sequence Number: 11307323
• Product Code: HWC
• UDI-Device Identifier: 10886982144751
• UDI-Public: (01)10886982144751
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• 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): 11/26/2018

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: 202.818
• Device Catalogue Number: 202.818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR