MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.543S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of postoperative nonunion and infection development is unknown.Original implant date is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.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 hardware removal was performed on (b)(6) 2017 due to an infection and nonunion in the tibia.Original implant date is unknown.One ti cannulated tibial nail and an unknown quantity of screws were removed.No revision at this time.This report is for one (1) 11 mm ti cannulated tibial nail-ex/315 mm-sterile.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 11MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7104498
• Report Number: 2939274-2017-50196
• Device Sequence Number: 685764
• Product Code: JDS
• UDI-Device Identifier: 10886982084453
• UDI-Public: (01)10886982084453(17)EXPIRATIONDATEUNKNOWN(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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: 04.004.543S
• Device Catalogue Number: 04.004.543S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/11/2017
• 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: 29 YR
• Patient Weight: 86