MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.004.452S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.No patient height reported.Date of event is unknown date in 2017.Device is not expected to return.(b)(4).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.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 the patient had original surgery on (b)(6) 2015 for treatment of a tibial fracture due to a skiing injury.Patient was implanted with one (1) cannulated tibial ex-nail, one (1) 5 mm end cap and three (3) 5.0 mm locking screws.On an unknown date post-operative, patient presented with knee pain.On (b)(6) 2017, surgeon removed all implants.It was reported that no fragments were generated during implant removal and all removed implants were reported in good condition.Removed implants have been retained by the patient.Revision surgery was completed successfully with no time delay.Patient is reported in stable condition.This is report 1 of 3 for (b)(4).

• Brand Name: 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-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: 7121335
• Report Number: 2939274-2017-50293
• Device Sequence Number: 13723143
• Product Code: JDS
• UDI-Device Identifier: 10886982084231
• UDI-Public: (01)10886982084231(17)EXPIRATIONUNKNOWN(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 11/17/2017

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: 04.004.452S
• Device Catalogue Number: 04.004.452S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/15/2017
• 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: 18 YR