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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 Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code (b)(4) lot b1496512 before the market release. No anomalies have been found. The original lot, manufactured in 2020, was comprised of 10 devices. All of them have already been distributed to the market. According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot. Technical evaluation the device involved has not yet been received by orthofix srl. The technical evaluation will be performed as soon as the device become available. 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 the results of the investigation are available, orthofix srl will provide a follow up report. Orthofix srl continues monitoring the devices on the market.
 
Event Description
The information provided by local distributor indicates: hospital name: (b)(6) hospital. Surgeon's name: (b)(6). Date of initial surgery: (b)(6) 2020. Body part to which device was applied: trochanteric fracture. Surgery description: fracture treatment. Patient's information: (b)(6) year-old, female, weight (b)(6) kg. , height 1. 60 cm, previous health condition: diabetes, high blood pressure, smoking. Problem observed during: into treatment/postoperative. Type of problem: device functional problem. Event description: "on the (b)(6) 2020, a patient was operated for a trochanteric fractured, treated with chimaera trochanteric nail. On december 16th, it was reported to our sales representative that a complication arose as the barrel of the sliding lag screw appeared totally apart lying into the soft tissue of the femur. " the complaint report form also indicated: the device failure had adverse effects on patient: loss of achieved correction, loss of stability. The initial surgery was completed with the device. The event did not lead to a delay in the duration of the surgical procedure. An additional surgery was required: a revision surgery is scheduled to take place in the following days. A medical intervention (outpatient clinic) was not required. Copy of operative reports are not available. Copy of x-ray images are available. Patient current health condition: n/a. Further information received from the local distributor on (b)(6) 2021: the revision surgery was completed last week and only the lag screw was extracted and replaced. The patient informed she had a fall thus, it is possible because of the fall, that the screw was detached from the nail. Further information received from the local distributor on (b)(6) 2021: copy of x-ray images after revision surgery. Patient's current health condition after revision surgery is satisfactory. Manufacturer ref: (b)(4). Distributor ref: (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, 37012
IT 37012
Manufacturer (Section G)
ORTHOFIX SRL
via delle nazioni, 9
bussolengo, verona, 37012
IT 37012
Manufacturer Contact
gianluca ricadona
via delle nazioni, 9
bussolengo, verona, italy 37012
IT   37012
MDR Report Key11168821
MDR Text Key233268199
Report Number9680825-2021-00004
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
K161466
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number99-T93790
Device Catalogue Number99-T93790
Device Lot NumberB1496512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/14/2021 Patient Sequence Number: 1
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