MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 9MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.346S
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
Device was used for treatment, not diagnosis.Patient identifier, age, date of birth, and weight not available for reporting.Date of infection onset is unknown date in 2017.: device is not expected to return.Device history review: manufacturing location: (b)(4).Manufacturing date: 09-may-2017; expiration date: 30-apr-2026.Component parts reviewed: raw material received from nf & m international.Certificate of report for titanium meet specification.Raw material receiving/putaway checklist meets requirement.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ 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 was originally implanted with a tibial nail and four unknown interlocking screws on an unknown date as treatment for a fracture.On an unknown date, post-operative, the patient developed an unspecified infection.Reportedly, the patient had redness and swelling around the incision site.It is unknown if the patient had pain or discomfort related to this event.The patient had hardware removal surgery on (b)(6) 2017 the tibial nail and four unknown screws were removed intact.No patient harm was reported.Cultures were collected during the surgery.The procedure was successfully completed.Patient outcome was reported stable.The explanted devices were disposed.The patient will be re-nailed at a future date.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
(b)(6).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: 9MM TI CANNULATED TIBIAL NAIL-EX/330MM-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: 7151243
• Report Number: 2939274-2017-50468
• Device Sequence Number: 786250
• Product Code: JDS
• UDI-Device Identifier: 10886982083913
• UDI-Public: (01)10886982083913(17)260430(10)H360720
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 11/29/2017

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 Expiration Date: 04/30/2026
• Device Model Number: 04.004.346S
• Device Catalogue Number: 04.004.346S
• Device Lot Number: H360720
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 01/24/2018
• 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