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
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11018874
• Report Number: 2939274-2020-05603
• Device Sequence Number: 4242169
• Product Code: HSB
• UDI-Device Identifier: 10886982089250
• UDI-Public: (01)10886982089250
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K120807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 04.016.225S
• Device Catalogue Number: 04.016.225S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention