MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 34MM; SCREW, FIXATION, BONE

Model Number	214.834
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This patient information is unknown.Date of postoperative infection development is unknown.Additional device product code: ktt.Original implant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 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 patient underwent removal of hardware on (b)(6) 2018 due to infection caused by the femur implants and pain caused by the tibial implants.Implants were originally implanted on an unknown date.Devices removed are one (1) titanium cannulated tibial nail, one (1) titanium end cap, two (2) titanium locking screw, one (1) locking compression (lcp) curved condylar plate, one (1) periprosthetic locking screw, one (1) locking screw, eight (8) cortex screws, and two (2) cannulated screw partially threaded.Procedure was successfully completed.There was no surgical delay.Patient outcome is unknown.This complaint involves total 17 devices.Complaint (b)(4) captures 10 devices.The remaining 7 devices have been captured under linked complaint (b)(4).This report is for one (1) 4.5 mm cortex screw self-tapping 34 mm this is report 7 of 10 for complaint (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 34MM
• 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: 7679765
• Report Number: 2939274-2018-52828
• Device Sequence Number: 1528473
• Product Code: HWC
• UDI-Device Identifier: 10886982154668
• UDI-Public: (01)10886982154668
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• 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): 06/14/2018

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: 214.834
• Device Catalogue Number: 214.834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR