MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9.5MM TI MULTILOC PROX HUMERAL NAIL/RT/CANN/160MM-STER ROD, FIXATION, INTRAMEDULLARY

Model Number 04.016.038S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 on (b)(6) 2019, the patient had hardware removal of  one (1) multiloc humeral nail, one (1) multiloc screw length 50mm, one (1) multiloc screw length 42mm, one (1) multiloc screw length 48mm, one (1) multiloc screw length 40mm, one (1) titanium locking screw length 34mm, and  one (1) titanium locking screw length 36mm due to shoulder pain and limited mobility of humerus. There were four part proximal humerus fracture fixed with the nail but the bone had gone on to die. The surgeon removed all the implants because the head just fell into various collapse and take the dead bony fragments. Initial surgery was done on (b)(6) 2018. It is unknown if there was a surgical delay. Procedure and patient outcome are unknown. This report is for one (1) 9. 5mm ti multiloc proximal humeral nail. This is report 1 of 7 for complaint (b)(4).

• Brand Name: 9.5MM TI MULTILOC PROX HUMERAL NAIL/RT/CANN/160MM-STER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8621210
• MDR Text Key: 145417926
• Report Number: 2939274-2019-58162
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 04.016.038S
• Device Catalogue Number: 04.016.038S
• Device Lot Number: 9221170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2014
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 05/17/2019 Patient Sequence Number: 1