MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 36MM; SCREW, FIXATION, BONE

Model Number	214.836
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
(b)(6).Date patient pain began is not known.(b)(4).Lot number unknown.Date of implant reported as 2016, exact date is not known.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient underwent a partial revision of total knee and knee manipulation, and was implanted with a 4.5mm variable angle locking compression plate (va-lcp) curved condylar plate, four (4) 4.5mm cortex screws, three (3) cannulated va locking screws, and two (2) 5.0mm cannulated va locking screws on unknown date in 2016.On unknown date patient reported pain and stiffness associated with the implants.Patient was returned to surgery on (b)(6) 2018 where all hardware was removed.Patient was not revised to any additional hardware as the fracture had healed.Surgery was completed successfully.Patient reported in stable condition.This report is for one (1) 4.5mm cortex screw 36mm.This is report 3 of 10 for (b)(4).
Additional Manufacturer Narrative
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.

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 36MM
• 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: 7328138
• Report Number: 2939274-2018-50980
• Device Sequence Number: 18869908
• Product Code: HWC
• UDI-Device Identifier: 10886982154675
• UDI-Public: (01)10886982154675(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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: 214.836
• Device Catalogue Number: 214.836
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 91