MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI CANNULATED HUMERAL NAIL-EX/270MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.001.234S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used to capture additional medical/surgical intervention required.Device history records review was completed for part# 04.001.234s, lot# 5288985.Manufacturing location: (b)(4) , manufacturing date: aug 03, 2006, expiry date: jun 30, 2015.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 patient underwent implant procedure on an unknown date.The patient subsequently developed a non-union.On (b)(6) 2018, the patient underwent a hardware removal of a titanium humeral nail expert and a titanium locking screw.During the surgery, surgeon removed the nail and one of the screws.The procedure was completed successfully.There was no surgical delay.Patient outcome is unknown.This report is for one (1) 7mm ti cannulated humeral nail-ex/270mm-sterile.This is report 1 of 2 for (b)(4).

• Brand Name: 7MM TI CANNULATED HUMERAL NAIL-EX/270MM-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: 7929485
• Report Number: 2939274-2018-54105
• Device Sequence Number: 16623003
• Product Code: JDS
• UDI-Device Identifier: 10886982080936
• UDI-Public: (01)10886982080936
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2018

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 Expiration Date: 06/30/2015
• Device Model Number: 04.001.234S
• Device Catalogue Number: 04.001.234S
• Device Lot Number: 5288985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 70