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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL SCREW EXTRACTOR SIZE 4 - 9MM

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ORTHOFIX SRL SCREW EXTRACTOR SIZE 4 - 9MM Back to Search Results
Model Number 193337
Device Problem Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 10/04/2019
Event Type  Injury  
Manufacturer Narrative
Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 193337 batch g001 before the market release. No anomalies have been found. The original lot, manufactured in 2017 was comprised of 30 devices. 26 of them have already been distributed to the market. Orthofix srl checked the internal records related to the controls made on the device code 99-t93025 batch ad1756 before the market release. No anomalies have been found. The original lot, manufactured in 2017 was comprised of 219 devices. All of them have already been distributed to the market. Orthofix srl checked the internal records related to the controls made on the device code 99-t93795 batch b1291742 before the market release. No anomalies have been found. The original lot, manufactured in 2019 was comprised of 100 devices. All of them have already been distributed to the market. Technical evaluation: the technical evaluation of the devices involved, received on 17 october 2019 is currently on going. 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 you with a follow up report. Orthofix srl continues monitoring the devices on the market. Please kindly refer also to mfr report number 9680825-2019-00073 and 9680825-2019-00074.
 
Event Description
The information provided by the local distributor indicates: hospital name: (b)(6). Surgeon's name: dr. (b)(6). Date of surgery: (b)(6) 2019. Body part to which device was applied: femur proximal surgery description: fracture treatment patient information: (b)(6) year-old, female, (b)(6) kg. , 168 cm. Problem observed during: clinical use on patient/intraoperative. Type of problem: device functional problem event description: screw extractor (ref 193337) got blocked in cephalic screw. This extraction of the lag screw was impossible with the extract device. When the device was put in july, as the lag screw was too short, the surgeon tried to extract it during (b)(6) surgery, with no success. So he probably damaged the lag screw thread during the first surgery. When they tried to extract the screw 3 months after, so last friday (b)(6), then couldn't get the tread. So they tried with the screw extractor (size 4-9mm) with the universal chuck to turn with no success. The screw extractor's thread and the lag screw thread completely cold welding. The complaint report form also indicates: the device failure had adverse effects on patient. The initial surgery was not completed with the device. A replacement device of same model was not immediately available to complete surgery: the surgery was completed with a hip prothesis. The event led to a clinically relevant increase in the duration of the surgical procedure: longest anesthesia. Timing of ablation longer than supposed. An additional surgery was not required. A medical intervention (outpatient clinic) was not required. Copies of the operative report are not available. Copies of the x-ray images are available (pre-operative images). Information about patient current health condition: ok. Further information received from the local distributor on 10th october 2019: the surgery of 4th was a replacement for prothesis. The screw too short gave pain to the patient. Pain in the hip. She could walk properly. So the decide to change it by a prothesis. (b)(4).
 
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Brand NameSCREW EXTRACTOR SIZE 4 - 9MM
Type of DeviceSCREW EXTRACTOR SIZE 4 - 9MM
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
roberto donadello
via delle nazioni, 9
bussolengo, verona, italy 37012
IT   37012
MDR Report Key9259367
MDR Text Key184179935
Report Number9680825-2019-00072
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
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 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number193337
Device Catalogue Number193337
Device Lot NumberG001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/31/2019 Patient Sequence Number: 1
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