MAUDE Adverse Event Report: ORTHOFIX SRL DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT

Model Number 1-1100701

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Analysis of historical records: the device involved in this event was discarded by the hospital.Unfortunately also the lot number has not been made available and therefore it was not possible to perform the verification of the historical data.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."i note that in this case the surgeon and the representative ensured that a drill bit was replaced immediately it was apparent that it was not functioning as it should.Harm to the patient was avoided.I agree with your reportability form for the usa, that serious injury did not occur but that the incident should be reported".Final comments: orthofix has received some complaints from the market of a lower cutting performance of drill bits.Orthofix (b)(4) 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bits historically manufactured.Orthofix determined that all drill bits manufactured in that limited period of time be withdrawn from the market (re.Us fda recall action number 9680825-09-27-2018-003-r and fsca201803).Orthofix (b)(4) can therefore suppose that the device involved in this event, belongs to a batch included in the recalled list.Orthofix (b)(4) would like to assure that drill bits manufactured before and after the indicated period have optimal cutting performance.Orthofix (b)(4) 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: unknown, body part to which device was applied: unknown, surgery description: correction, patient's information: unknown, problem observed during: clinical use on patient/intraoperative, type of problem: device functional problem.Event description: "during a surgery recently at (b)(6) hospital with dr.(b)(6), drill bit 1-1100701 (no lot # available), this drill bit wasn't cutting bone quickly and to avoid any burning of the cortex, the rep supplied another drill bit for the doctor to use.The first drill bit was trashed and will not be returning to (b)(6)".The complaint report form also indicates: the device failure did not have any adverse effects on patient, the initial surgery was not completed with the device, a replacement device was immediately available to complete the surgery, the event did not lead to a clinically relevant increase in the duration of the surgical procedure, 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: no response.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).

• Brand Name: DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT
• Type of Device: DRILL BIT D.4,8 MM L.280 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: 7998785
• MDR Text Key: 126242921
• Report Number: 9680825-2018-00091
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1-1100701
• Device Catalogue Number: 1-1100701
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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