MAUDE Adverse Event Report: ORTHOFIX SRL DRILL BIT D.4,8 MM L.180 MM TIN COATED - QUICK CONNECT

Model Number 1-1100101

Device Problem Dull, Blunt (2407)

Patient Problem Unspecified Infection (1930)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the drill bit code 1-1100101 lot 289813 before the market release.No anomalies have been found.The original lot, manufactured in 2018, 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 first complaint received in regards to this specific device lot.Technical evaluation: a technical evaluation of the drill bit concerned was not performed as the device was discarded by the hospital and therefore not available for the investigation.Medical evaluation: the information made available on the event was sent to our medical evaluator.Please find below an extract of the medical evaluation performed: "in this case a drill bit was being used that is part of a batch known to be substandard and the subject of a product recall.The drill bit would not drill the hole very easily and produced smoke from the drilling site.A fixator was applied, and 2 weeks later the fixation was converted to a plate.Burnt skin was identified at this operation and was excised.We do not know but i suspect that skin closure was achieved.It is very likely that this patient will also develop a ring sequestrum of dead bone around the screw site.There is a risk of infection and osteomyelitis".Final comments: orthofix has received some complaints from the market of a lower cutting performance of drill bits.Orthofix srl conducted an investigation by performing technical analysis, medical evaluations and a review of the risk analysis.The result of the investigation determined that some production batches of drill bits, manufactured in a limited period of the years 2017/2018, show a lower cutting performance compared to drill bits historically manufactured.Orthofix determined that all drill bits manufactured in that limited period of time be withdrawn from the market (re.Us fda recall action number 9680825-09-27-2018-003-r and fsca201803).Orthofix srl would like to inform you that the device involved in this event belongs to a batch included in the recalled list.Orthofix srl would like to assure that drill bits manufactured before and after the indicated period have optimal cutting performance.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6) hospital.Surgeon name: dr.(b)(6).Date of initial surgery: (b)(6) 2018.Body part to which device was applied: lower extremity - distal tibia fractures.Surgery description: fracture treatment.Patient's information: 40's, male.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "the surgeon could not drill the bone with a drill in the galaxy fixator kit (pelvis sterile kit).The drilling force of the drill bit was bad compared to usual.We are reported to have smoked from the patient's bone during drilling.Therefore, it burned the patient's skin.About two weeks later they performed conversion surgery on the plate from the external fixator.At the time of conversion surgery the surgeon cut out the burned skin of the patient for the treatment.Since the drill was thrown away at the hospital, we can not return it to you.We already reported this event to the (b)(6) ((b)(6) authority)".The complaint report form also indicates: the device failure had adverse effects on patient (other).The initial surgery was completed with the device.The event led to a clinically relevant increase in the duration of the surgical.Procedure (the time to drill was longer than usual by a few minutes).An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copies of the operative reports are not available.Copies of the x-ray images are not available.Patient current health condition: unknown.On october 4, 2018, orthofix srl received the following details from the local distributor: "regarding the current health condition of the patient, we have not gotten any information in particular".Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).

• Brand Name: DRILL BIT D.4,8 MM L.180 MM TIN COATED - QUICK CONNECT
• Type of Device: DRILL BIT D.4,8 MM L.180 MM TIN COATED - QUICK CONNECT
• 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 Key: 7998791
• MDR Text Key: 124814826
• Report Number: 9680825-2018-00090
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1-1100101
• Device Catalogue Number: 1-1100101
• Device Lot Number: 289813
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 9680825-09-27-2018-003-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR