MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM TI RECON SCREW WITH T25 STARDRIVE 90MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.003.028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: (b)(4).Date of infection is not known.(b)(4), lot number unknown.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 that a hardware removal took place due to infection close to implant site.Patient was originally implanted on (b)(6) 2016 with a nail for a femoral shaft fracture.Patient now wanted the parts out.There was a non-related injury to the medial side of the knee (abrasion) and that site got infected which corresponded to one of the screws¿ paths.Patient was concerned that the infection would get to the implant.Patient was healed at the implant site.Patient ended up with an antibiotic nail made up of cement and gentamicin.Procedure completed successfully and patient was in stable condition.This report is for one (1) 6.5mm recon screw 90mm.(b)(4).

• Brand Name: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 90MM
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7327677
• Report Number: 2939274-2018-50965
• Device Sequence Number: 13860445
• Product Code: HSB
• UDI-Device Identifier: 10886982081599
• UDI-Public: (01)10886982081599(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• 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
• 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: 04.003.028
• Device Catalogue Number: 04.003.028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/09/2018
• 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: 69 YR
• Patient Weight: 87