MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 12MM; SCREW, FIXATION, BONE

Model Number	204.812
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reported as 5¿4¿.Additional product codes: hrs, jds.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 the patient underwent a hardware removal procedure due to pain on (b)(6) 2018.Hardware removed during the procedure involves one (1) locking compression plate (lcp) one-third tubular plate with collar, one (1) variable angle lcp medial distal tibia plate, seven (7) cortex screws, two (2) locking screws with stardrive and five (5) variable angle locking screws with t8 stardrive.The hardware was implanted on an unknown date.During the procedure the five (5) variable angle locking screws broke.The broken screws were fully removed.The bone was healed and no additional hardware was implanted.The surgery was successfully completed with no surgical delay.The patient outcome is unknown.This report addresses the revision surgery due to pain.Additional products involved are addressed in (b)(4).The intraoperative issue with the broken screws is addressed in (b)(4).This report is for one (1) 3.5mm cortex screw.This is report 5 of 6 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 12MM
• 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: 7978677
• Report Number: 2939274-2018-54472
• Device Sequence Number: 11107700
• Product Code: HWC
• UDI-Device Identifier: 10886982146243
• UDI-Public: (01)10886982146243
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 204.812
• Device Catalogue Number: 204.812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 72