MAUDE Adverse Event Report: SYNTHES USA 6.5MM TI RECON SCREW WITH T25 STARDRIVE 80MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.003.026S

Device Problem Failure to Align (2522)

Patient Problems Sedation (2368); Blood Loss (2597); No Code Available (3191)

Event Date 03/09/2016

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.(b)(4) although the exact desired result was not obtained, the device was not removed.Remains in situ.The complainant parts are not expected to be returned for manufacturing review/investigation.(b)(6).(b)(4).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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent a proximal femur nailing procedure on (b)(6) 2016.The utilized screws were designed to be inserted along a specified path with the assistance of a zig/aiming arm.However, the screw did not go through properly and wound up missing the nail.The surgeon opened the fracture site and manually corrected the screw position with the use of bone cement.In doing so, a suboptimal result was achieved.The procedure was completed with a two (2) hour delay and additional blood loss due to the required medical intervention.This report is 1 of 4 for (b)(4).

• Brand Name: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 80MM-STERILE
• 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: 5519399
• MDR Text Key: 40939421
• Report Number: 2520274-2016-11794
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PK040336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.003.026S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 03/23/2016
• 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