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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL CHIMAERA HFS LAG SCREW SLIDING L90MM STERILE

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ORTHOFIX SRL CHIMAERA HFS LAG SCREW SLIDING L90MM STERILE Back to Search Results
Model Number 99-T93790
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t93790 lot v1431055 before the market release. No anomalies have been found. The original lot, manufactured in 2016, was comprised of (b)(4) devices. All of them have already been released to the market. According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot. Technical evaluation: the device involved in this event was received at orthofix (b)(4) on (b)(6) 2018. The technical evaluation is ongoing. Medical evaluation: the information made available on the case was sent to our medical evaluator. A preliminary medical evaluation was performed and will be finalized once the results of the investigation are available. As soon as further information on the case is available, orthofix (b)(4) will provide you with a follow up report. Orthofix (b)(4) continues monitoring the devices on the market. (b)(4).
 
Event Description
The information provided by the local distributor indicates: hospital name: (b)(6); surgeon's name: dr. (b)(6); date of initial surgery: (b)(6) 2018; body part to which device was applied: n/a; surgery description: fracture treatment; patient information: n/a; problem observed during: into treatment/post-operative; event description: femoral neck was not properly reduced and fixed in a neck angle greater than what is recommended. The main lag screw broke as per attached pictures. Nail was extracted, and chimaera was used for re fixation. The initial procedure was done at (b)(6) hospital. The 2nd procedure was done at (b)(6) on (b)(6) 2018 the complaint report form also indicates: the device failure had adverse effects on patient: loss of fracture reduction and loss of achieved correction. The initial surgery was completed with the device. An additional surgery was required following device failure: performed on (b)(6) 2018. Copies of the operative reports are not available copies of the x-ray images are available. Patient current health condition: n/a. On (b)(6) 2018, orthofix (b)(4) received copy of x-ray images and the following further information: "please find attached form and x-rays in connection with a broken lag screw with chimaera nail. The surgeon whom initially performed surgery struggled to reduce the neck angle sufficiently. On the x-rays you can see a broken k-wire in an attempt to reduce femoral neck angle. The femoral neck was fixed in an angle greater than what is described as normal parameters. The patient presented with a broken lag screw to (b)(6) approximately 9 months after initial surgery. " on (b)(6) 2018, orthofix (b)(4) received the following further information: "the patient is being followed up as an outpatient through clinic, i have requested information from dr and awaiting his response. " manufacturer reference number: (b)(4).
 
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Brand NameCHIMAERA HFS LAG SCREW SLIDING L90MM STERILE
Type of DeviceCHIMAERA HFS LAG SCREW SLIDING L90MM STERILE
Manufacturer (Section D)
ORTHOFIX SRL
via delle nazioni, 9
bussolengo, verona, italy 37012
IT 37012
Manufacturer (Section G)
ORTHOFIX SRL
via delle nazioni, 9
bussolengo, verona, italy 37012
IT 37012
Manufacturer Contact
roberto donadello
via delle nazioni, 9
bussolengo, verona, italy 37012
IT   37012
MDR Report Key8145793
MDR Text Key129751925
Report Number9680825-2018-00103
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K161466
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/20/2021
Device Model Number99-T93790
Device Catalogue Number99-T93790
Device Lot NumberV1431055
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/10/2018 Patient Sequence Number: 1
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