Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL LAG SCREWDRIVER RETENTION ROD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ORTHOFIX SRL LAG SCREWDRIVER RETENTION ROD Back to Search Results
Model Number 193282
Device Problem Mechanical Problem (1384)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 02/10/2018
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 193282 lot 1707942 before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the second complaint notified from this specific device lot.Technical evaluation: the device involved in this event has not yet been received by orthofix (b)(4).Orthofix (b)(4) is strictly in contact with the local distributor to have the available portion of the device concerned.The technical evaluation of the device involved will be performed as soon as the device becomes available.Medical evaluation: the information 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 technical evaluation are available.Orthofix (b)(4) has requested further information on the event such as copies of the operative reports, copies of the x-ray images, information on patient current health condition and the device availability for the technical evaluation.Unfortunately, this information has not yet been made available.As soon as the results of the investigation and/or further information are available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.
 
Event Description
On march 20, 2018, orthofix (b)(4) received through the us agent, orthofix inc, the fda medwatch ref: mw5075573 which includes the following event description: "orthopedic procedure: position of lag screw was not the desired position.He attempted to remove lag screw with instruction of the ortho rep.Attempts were unsuccessful, which resulted in the extended surgery time.Final attempt resulted in instrument malfunction and breakage of tip of instrument which remained in the pt.Diagnosis or reason for use: hip fracture - orif".On march 21, 2018, orthofix (b)(4) received from the us agent, orthofix inc, the complaint report form with the following details: product code: 193282 (lag screwdriver retention rod).Batch number: 1707942.Quantity: 1.Hospital name: (b)(6) hospital.Surgeon name: dr (b)(6).Date of initial surgery: (b)(6) 2018.Body part to which device was applied: hip.Surgery description: fracture treatment.Patient information: (b)(6), female.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: doctor had placed the screw in the wrong position.When trying to reposition the screw he could not get a good x-ray.He removed the jig and tried to free hand removal of the screw.The tip of the retention rod broke off inside the lag screw.The lag screw with the tip remained in the patient.A revision surgery (date unknown) was performed to replace the chimaera with a hemi arthroplasty.The lag screw and tip of the retention rod were discarded at the hospital during revision surgery.The complaint report form also indicates: the device failure had adverse effects on patient (un-retrieved device fragments).The initial surgery was completed with the device.The event led to a clinically relevant increase in the duration of the surgical procedure (30 minute delay).An additional surgery was required (date of the additional surgery is unknown.Ofix rep was not present during revision).Copies of the operative reports are not available (the op report has been requested but not made available yet).Copies of the x-ray images are not available (x-rays have been requested but not made available yet).Patient current health condition: no response.Fda ref: mw5075573.(b)(4).
 
Manufacturer Narrative
Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 193282 lot 1707942 before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the second complaint notified from this specific device lot.Technical evaluation: a technical evaluation of the device concerned was not possible as the device has not been returned to orthofix srl (the tip of the retention rod was discarded by the hospital during revision surgery while the stem of the retention rod was not returned).Medical evaluation: the information made available on the case was sent to our medical evaluator.Please find below an extract of the medical evaluation performed."in this patient, a 60 year old female, a chimaera nailing system was being used for a proximal femoral fracture.The surgeon apparently did not get one of the lag screws into the correct position; we are initially told that it was the supplementary lag screw, and then the lag screw.During unorthodox attempts to remove the lag screw for re-insertion the tip of the screwdriver broke off inside the patient.We do not have details, but the fixation was apparently not good enough to leave and a hemiarthroplasty was performed instead.This is perfectly acceptable treatment for a femoral neck fracture, but in many cases internal fixation is preferred.It seems to me that the reasons for the failure of the equipment in this case were: fixation of the fracture in the wrong position, almost certainly because there was not room for a supplementary lag screw, because the main lag screw was too proximal.Very unorthodox attempts at removal of the supplementary lag screw that finally caused it to break.Instrument usage not within the design criteria.It seems clear that the causes of this failure were related to the circumstances of this particular operation." final comments: a technical evaluation of the device concerned was not possible as the device has not been returned to orthofix srl (the tip of the retention rod was discarded by the hospital during revision surgery while the stem of the retention rod was not returned).The technical evaluation will be performed in case the stem of the retention rod becomes available.A complete medical evaluation of the case was not performed as no information about the medical procedure, diagnosis and x-rays have been made available.Orthofix srl has requested further information on the event such as copies of the operative reports, copies of the x-ray images, information on patient current health condition and the device availability for the technical evaluation.Unfortunately, this information has not been made available.Considering the lack of information provided, it is not possible to conduct any investigation and therefore to draw any conclusion in regards to the complained retention rod breakage.If further information and/or the device involved are received, orthofix srl will promptly re-open the investigation on the case.Orthofix srl continues monitoring the devices on the market.
 
Event Description
On march 20, 2018, orthofix srl received through the us agent, orthofix inc, the fda medwatch ref: mw5075573 which includes the following event description: "orthopedic procedure: position of lag screw was not the desired position.He attempted to remove lag screw with instruction of the ortho rep.Attempts were unsuccessful, which resulted in the extended surgery time.Final attempt resulted in instrument malfunction and breakage of tip of instrument which remained in the pt.Diagnosis or reason for use: hip fracture - orif." on march 21, 2018, orthofix srl received from the us agent, orthofix inc, the complaint report form with the following details: product code: 193282 (lag screwdriver retention rod).Batch number: 1707942.Quantity: 1.Hospital name: (b)(6) hospital.Surgeon name: dr (b)(6).Date of initial surgery: (b)(6) 2018.Body part to which device was applied: hip.Surgery description: fracture treatment.Patient information: r.V., 66 years, female.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: doctor had placed the screw in the wrong position.When trying to reposition the screw he could not get a good x-ray.He removed the jig and tried to free hand removal of the screw.The tip of the retention rod broke off inside the lag screw.The lag screw with the tip remained in the patient.A revision surgery (date unknown) was performed to replace the chimaera with a hemi arthroplasty.The lag screw and tip of the retention rod were discarded at the hospital during revision surgery.The complaint report form also indicates: the device failure had adverse effects on patient (un-retrieved device fragments).The initial surgery was completed with the device.The event led to a clinically relevant increase in the duration of the surgical procedure (30 minute delay).An additional surgery was required (date of the additional surgery is unknown.Ofix rep was not present during revision).Copies of the operative reports are not available (the op report has been requested but not made available yet).Copies of the x-ray images are not available (x-rays have been requested but not made available yet).Patient current health condition: no response.No other information has been made available.Fda ref: mw5075573.Orthofix srl ref: (b)(4).Orthofix inc ref: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LAG SCREWDRIVER RETENTION ROD
Type of Device
LAG SCREWDRIVER RETENTION ROD
Manufacturer (Section D)
ORTHOFIX SRL
via delle nazioni, 9
bussolengo, verona, italy 37012
IT  37012
MDR Report Key7420601
MDR Text Key105151936
Report Number9680825-2018-00030
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K161466
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number193282
Device Catalogue Number193282
Device Lot Number1707942
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
-
-