MAUDE Adverse Event Report: SYNTHES USA; CERCLAGE FIXATION

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

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Event Description

It was reported that a patient had a helical blade placed in treatment of a hip and shattered femur.Since treatment from orthopedist and rheumatologist, patient experiences signs and symptoms of constant ache and pain.It was also reported that the patient is concerned that he may possibly be having a titanium reaction.Doctor's recommendation is a full hip replacement if constant ache continues.To date no explant is scheduled.This report is for an unknown cerclage wire.This is report 3 of 4 for (b)(4).

Manufacturer Narrative

Unknown cerclage wire/unknown lot.Device has not been explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4100896
• MDR Text Key: 4834091
• Report Number: 2520274-2014-13736
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2014
• 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