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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL HUMERAL DISTRACTOR CLAMP
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ORTHOFIX SRL HUMERAL DISTRACTOR CLAMP Back to Search Results
Model Number 93431
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Analysis of historical records (please also kindly refer to mfr report 9680825-2020-00056 and 9680825-2020-00057).The devices involved in this event have not yet been received by orthofix srl.Unfortunately also the lot numbers have not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation (please also kindly refer to mfr report 9680825-2020-00056 and 9680825-2020-00057).The devices involved in this event have not yet been received by orthofix srl.Orthofix srl is strictly in contact with the local distributor to have the devices concerned.The technical evaluation will be performed as soon as the devices become available.Medical evaluation: the little information made available on the case was sent to our medical evaluator.The medical evaluation is currently on going and will be closed once further information on the case will be available.Orthofix srl has requested further information on the event such as devices batch number, patient information (age, sex and weight), copy of the operative report, copy of the pre and post-operative x-rays, information on patient current health condition and the devices availability for the technical evaluation.Unfortunately, this information has not been made available.As soon as further information is available, orthofix srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.
 
Event Description
On october 7, 2020, orthofix srl received from the (b)(6) distributor the following information: the patient informed that in 2012 had several operations to the right arm for a stiff elbow and appears to be building a case against the hospital, to claim compensation for permanent injury.(b)(4).
 
Manufacturer Narrative
Analysis of historical records (please also kindly refer to mfr report 9680825-2020-00056 and 9680825-2020-00057) the devices involved in this event have not returned to orthofix srl.Unfortunately also the lot numbers have not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation (please also kindly refer to mfr report 9680825-2020-00056 and 9680825-2020-00057) a technical evaluation of the devices involved was not possible, as they were not returned to orthofix srl.The technical evaluation will be performed should the devices become available.Medical evaluation the limited information made available on the event was sent to our medical evaluator.Please find below his comments."it is difficult to make any detailed comment about this incident as we have very few details and none of the components of concern or what procedure was carried out on the patient".Conclusions a technical evaluation of the devices involved was not possible, as they were not returned to orthofix srl.The technical evaluation will be performed should the devices become available.Unfortunately, no information about lot involved is available, therefore it is not possible to perform any technical investigation.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 devices batch number, patient information (age, sex and weight), copies of the operative report, copies of the pre and post-operative x-rays, information on patient current health condition and the devices availability for the technical evaluation.Unfortunately, this information was not made available.Considering the limited information provided, it is not possible to conduct any investigation and therefore to draw any conclusion in regards to the event/s occurred.Orthofix srl continues monitoring the devices on the market.Should further information and/or the devices concerned are received, orthofix srl will promptly finalize the investigation.
 
Event Description
On (b)(6) 2020, orthofix srl received from the dutch distributor the following information: the patient informed that in 2012 had several operations to the right arm for a stiff elbow and appears to be building a case against the hospital, to claim compensation for permanent injury.The devices involved are the three devices listed below: device code 93431 batch unknown (orthofix srl ref: (b)(4), mfr report 9680825-2020-00055); device code 93432 batch unknown (orthofix srl ref: (b)(4), mfr report 9680825-2020-00056); device code 932200 batch unknown (orthofix srl ref: (b)(4), mfr report 9680825-2020-00057).Communication received on november 2, 2020: "the patient does not want to inform us where and when and by whom the surgery was performed.He only wants to know if the devices used were ce marked and registered at the time of his surgery in 2012".No other information was made available on this event.
 
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Brand Name
HUMERAL DISTRACTOR CLAMP
Type of Device
HUMERAL DISTRACTOR CLAMP
Manufacturer (Section D)
ORTHOFIX SRL
via delle nazioni, 9
bussolengo, verona, 37012
IT  37012
MDR Report Key10777364
MDR Text Key217145882
Report Number9680825-2020-00055
Device Sequence Number1
Product Code KTT
Combination Product (y/n)N
PMA/PMN Number
K113770
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number93431
Device Catalogue Number93431
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Disability;
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