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

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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 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
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11872507
• MDR Text Key: 252381654
• Report Number: 2939274-2021-02532
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982080943
• UDI-Public: (01)10886982080943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 04.001.236S
• Device Catalogue Number: 04.001.236S
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention