MAUDE Adverse Event Report: SYNTHES USA 130 DEG ANGLED BLADE PLATE 4 HOLES/70MM/60MM; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Catalog Number 283.44

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

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.(b)(4).Device broke during the procedure.Plate was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device code used to capture x-ray taken and additional medical/surgical intervention required.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2016, patient underwent a revision surgery to repair a sub-trochanteric fracture.During the procedure, a 130 degree angled blade plate cracked the proximal femur on final insertion.The sub-trochanteric fracture location was at the level of an old screw hole from a previously removed plate.It is unknown if the previous devices from the original implant are synthes devices.As the surgeon was performing the final insertion of the plate at the lateral wall, the proximal femur cracked.The plate was immediately removed.The sub-trochanteric fracture and the subsequent cracked lateral wall was treated with biomet variable angle hip screw.The length of the time delay is unknown.Surgery was completed successfully, patient status and outcome following the procedure was as expected.This report is for one (1) 130 degree angled blade plate.This is report 1 of 1 for (b)(4).

• Brand Name: 130 DEG ANGLED BLADE PLATE 4 HOLES/70MM/60MM
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6093438
• MDR Text Key: 59618107
• Report Number: 2520274-2016-15338
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 283.44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2016
• 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