MAUDE Adverse Event Report: SYNTHES USA; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Collapse (2416); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient weight is unknown.Date of post-operative event is unknown.This report is for one (1) unknown lag screw.(other): without a valid part and lot number, the udi is not available.Per facility, the complainant parts will not be returned for manufacturer review/investigation.(b)(4).Unknown, as specific part and lot numbers for the complainant screw were not provided.However, the likely 510k (based on the type of construct) is k131548.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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 a patient was originally treated for a hip fracture with the implantation of a trochanteric femoral nail advanced (tfna) system on (b)(6) 2016.The construct included the following devices: one (1) femoral nail, one (1) lag screw, and two (2) locking bolts.On an unknown post-operative date, the patient presented with a collapsed femoral neck and femoral head bone.As a result, the patient was returned to the operating room for revision surgery on (b)(6) 2016.During the revision, the surgeon successfully removed all of the original tfna hardware with no reported issues.The patient was then revised to a depuy total hip replacement.The patient's status post-operatively was reported as stable.This report is for one (1) unknown lag screw.This report is 1 of 3 for (b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5632301
• MDR Text Key: 44425515
• Report Number: 2520274-2016-12545
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2016
• 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