MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 28MM; SCREW, FIXATION, BONE

Model Number	204.828
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: 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.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 unknown date, a patient had full body rash which began after an ankle fracture repair with one (1) 3.5 mm lcp one-third tubular plate and eight (8) 3.5 mm cortex screws.Allergy testing has confirmed the patient is allergic to indium (iii) chloride, a compound found in some metal alloys which maybe of the implants.No further information provided.This report is for one (1) 3.5mm cortex screw self-tapping 28mm this is report 3 of 9 for complaint pc-(b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 28MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13793175
• Report Number: 2939274-2022-00903
• Device Sequence Number: 3906814
• Product Code: HWC
• UDI-Device Identifier: 10886982146328
• UDI-Public: (01)10886982146328
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Model Number: 204.828
• Device Catalogue Number: 204.828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5 CRTX SCR LOW PROF HD STPING/SD/10; 3.5 CRTX SCR LOW PROF HD STPING/SD/12; 3.5 CRTX SCR LOW PROF HD STPING/SD/14; 3.5 CRTX SCR LOW PROF HD STPING/SD/18; 3.5 CRTX SCR LOW PROF HD STPING/SD/20; 3.5MM CORTEX SCREW SELF-TAPPING 75MM; 3.5MM CORTEX SCREW SELF-TAPPING 75MM; ONE-THIRD TUBULAR PL COLLAR 7 HOLES/85
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown