MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.016.035S

Device Problem Failure to Align (2522)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

Expiration date and lot number unknown.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.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.

Event Description

It was reported that on (b)(6) 2019, the aiming arm and protection sleeve missed the two (2) distal nail holes in multiloc nail.This was discovered after the two (2) titanium locking screws were implanted.On radiographic review, the two (2) titanium locking screws were in the bone but not in the nail.The surgeon removed the two (2) titanium locking screws.Two (2) new screws were inserted into the nail via freehand targeting technique.It was suspected that the aiming arm came loose during the nail insertion which cause the mal-alignment.The screw holes targeted as planned on the back table during a practice test.There was a surgical delay of ten (10) minutes.Procedure outcome was successfully completed.Patient outcome was unknown.This complaint involves five (5) devices.This report is for one (1) 8mm ti multiloc prox humeral nail/left/cann/160mm-ster.This report is 3 of 5 for (b)(4).

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).Investigation summary: product was not returned.All items functioned correctly after post surgical inspection.Device was used for treatment, not diagnosis.

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.

• Brand Name: 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/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
• MDR Report Key: 8344404
• MDR Text Key: 136297183
• Report Number: 2939274-2019-56482
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982089199
• UDI-Public: (01)10886982089199
• Combination Product (y/n): N
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.016.035S
• Device Catalogue Number: 04.016.035S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR