MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 32MM; SCREW, FIXATION, BONE

Model Number	214.832
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id: (b)(6).Date of event is unknown.Additional product code: ktt.Lot number is unknown.Without a lot number the device history records review could not be completed.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 that a patient had an original open reduction internal fixation (orif) of a periprosthetic fracture of total hip stem on (b)(6) 2018.A long broad curved plate was used with cables to fix the fracture.Patient later suffered a new fracture distal to the plate and the surgeon revised the original plate by removing it and replacing it with a 4.5 va-lcp curved condylar plate and cables on (b)(6) 2018.The original construct did not fail.It was removed to revise to a new plate.There was no surgical delay.The procedure was completed successfully.Patient disposition is unknown.This report is for a 4.5mm cortex screw self-tapping 32mm.This is report 1 of 2 for (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 32MM
• 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: 7487830
• Report Number: 2939274-2018-52027
• Device Sequence Number: 1976612
• Product Code: HWC
• UDI-Device Identifier: 10886982154651
• UDI-Public: (01)10886982154651
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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: 214.832
• Device Catalogue Number: 214.832
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/04/2018
• 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: 83 YR
• Patient Weight: 80