MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.016.225S

Device Problem Expiration Date Error (2528)

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

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.(b)(4).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 on (b)(6) 2020, during an intermedullary nail of the humerus using the multiloc humeral nailing system, the nail that the surgeon wanted was expired.The surgeon wanted the l 7mmx225mm humeral nail and ended up using an unknown l 7mmx195mm humeral nail.The surgeon was notified of other diameter options of the same length and the same diameter options with different lengths.The procedure was completed successfully with no surgical delay.The patient outcome was unknown.This report involves one (1) 7mm ti multiloc humeral nail right/cann/225mm-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11018874
• MDR Text Key: 221742207
• Report Number: 2939274-2020-05603
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982089250
• UDI-Public: (01)10886982089250
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2020

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: 04.016.225S
• Device Catalogue Number: 04.016.225S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention