MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7 TI CANNULATED HUMERAL NAIL-EX/280-SILE; NAIL, FIXATION, BONE

Model Number	04.001.236S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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, the patient underwent removal surgery of a broken titanium cannulated humeral nail.Patient outcome was unknown.Concomitant devices reported: unknown spiral blade (part# unknown, lot# unknown, quantity 1), unknown locking screw (part# unknown, lot# unknown, quantity unknown), unknown end cap (part# unknown, lot# unknown, quantity 1).This report is for 1 7mm ti cannulated humeral nail-ex/280mm-sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 7 TI CANNULATED HUMERAL NAIL-EX/280-SILE
• 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: 11872507
• Report Number: 2939274-2021-02532
• Device Sequence Number: 19650665
• Product Code: JDS
• UDI-Device Identifier: 10886982080943
• UDI-Public: (01)10886982080943
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K033071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: 04.001.236S
• Device Catalogue Number: 04.001.236S
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/24/2021
• 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