MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM TI MULTILOC SCREW LENGTH 42MM; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.019.042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); No Code Available (3191)
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 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) 4.5mm ti multiloc screw 42mm.This is report 3 of 7 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
05/21/2019: updated event description: it was reported that on (b)(6) 2019, the patient had hardware removal due to non union, 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 remove all the implants easily because the head just fell into various collapse and take the dead bony fragments.Initial surgery was on (b)(6) 2018.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.This complaint involves seven (7) devices.

• Brand Name: 4.5MM TI MULTILOC SCREW LENGTH 42MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8621240
• Report Number: 2939274-2019-58164
• Device Sequence Number: 13998835
• Product Code: HSB
• UDI-Device Identifier: 10886982089847
• UDI-Public: (01)10886982089847
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 04.019.042
• Device Catalogue Number: 04.019.042
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 79