MAUDE Adverse Event Report: ORTHOFIX SRL CANNULATED DRILL BIT, 3.0/3.5MM BITE COMPRESSION SCREW, QUICK CONNECT

Model Number 001-A-30001

Device Problem Dull, Blunt (2407)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/22/2018

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 001-a-30001 lot b1195371 before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of 40 devices.All of them have already been released to the market.Orthofix (b)(4) checked the internal records related to the controls made on the device code 001-a-1102p lot b1204948 before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4) kits devices.(b)(4) of them have already been released to the market.Technical evaluation: the devices involved in this event have not yet been received by orthofix (b)(4).The technical evaluation will be performed as soon as the devices become available.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 failure investigation are available.As soon as further information will be available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Please kindly refer also to mfr report number 9680825-2018-00061 and 9680825-2018-00062.

Event Description

The information initially provided by the local distributor indicates: hospital name: (b)(6) hospital; surgeon name: (b)(6); date of initial surgery: (b)(6) 2018; body part to which device was applied: right first metatarsal; surgery description: distal bunionectomy; patient information: (b)(6), female; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem.Event description: per tm (b)(6); during a distal bunionectomy with dr.(b)(6).2 drill bits with part # 001-a-30001 and lot b1195371 both drill bits used would not go through the bone.Or pulled a set that belonged to a competitor in order to complete the surgery.Un-retrieved guide wire w/part# 001-a-1102p lot b1204948 was left in patient's right metatarsal.This increased the duration of the procedure by 5-8 min.No additional surgery required.X-rays images are attached.The complaint report form also indicates: the device failure had adverse effects on patient: left k-wire in patient's right metatarsal toe the surgery was not completed with the device.A replacement device of the same model was not immediately available to complete the surgery the event led to an increase in the duration of the surgical procedure of 5-8 minutes to find replacement drill bit.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.Patient current health conditions: nothing to report.(b)(4).Please kindly refer also to mfr report number 9680825-2018-00061 and 9680825-2018-00062.

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 001-a-30001 lot b1195371 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 released to the market.Orthofix srl checked the internal records related to the controls made on the device code 001-a-1102p lot b1204948 before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4) kits devices.(b)(4) of them have already been released to the market.Technical evaluation: the returned devices (cannulated drill bits), received on august 1st, 2018, were examined by orthofix srl quality engineering department.The devices were subjected to visual and dimensional check as per orthofix specification.The visual check evidenced that the tip of both devices is damaged.The dimensional check performed where possible did not evidence any anomalies.It was not possible to perform the functional check as the devices are damaged.One defective item (as the lot number is the same for both devices), was then sent to an external laboratory to check the raw material.The composition of the raw material resulted conforming to design specifications.Medical evaluation: the information made available on the case together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluation performed.(b)(6) 2018.In this case two drill bits being used to drill holes for a cannulated screw.The drill bits did not perform the required function of drilling the bone, so another system was used to do this.A new (competitor's) drill bit was used, but the guide wire broke and was left in situ.It seems that the screws were inserted as planned, so the operation was completed with a +/- 10 minute delay.Because the drill bits failed in their primary function, and a broken guide wire fragment was left in situ, this event has been classed as a serious injury.It is not possible to comment on why this event might have happened, as we have very little information.15 august 2018 with the outcome of the technical analysis in this case some cannulated drill bits would not perform their primary function and use of a competitor's drill bit was required to complete the operation.The technical analysis suggests that the returned items were manufactured according to specification.However, it was not possible to test the functionality of the items because the tips were damaged.We can then assume that the drill bits had been subject to wear and tear and were blunt as a result.I note from the information supplied by the quality engineering department that these drill bits were conforming to specifications and that the design of the cutting surfaces has not changed.It therefore remains a mystery that these 2 drill bits failed to perform their primary function.Something caused the drill bit tips to become severely damaged and unusable, and when supplied originally they were according to specification and should have performed as expected.I agree that we can offer no sensible explanation.Final comments: the results of the failure investigation concluded as follows: 1.The devices code 001-a-30001 (cannulated drill bits), lot b1195371 were conforming to orthofix specification.No anomalies have been found.Based on the little information provided on the event, it was not possible to finalize the investigation and determine the root cause of the event notified; 2.It was not possible to perform the technical evaluation of item 001-a-1102p (guide wire), lot b1204948, as it was not returned to orthofix srl.In case further information is provided, orthofix srl will promptly re-open the investigation on the case.Orthofix srl continues monitoring the devices on the market.Please kindly refer also to mfr report number 9680825-2018-00061 follow up 1 and 9680825-2018-00062 follow up 1 - attachment: [2018155_fda medwatch cover letter follow up 1.Pdf].

Event Description

The information initially provided by the local distributor indicates: hospital name: (b)(6) hospital; surgeon name:(b)(6) ; date of initial surgery: (b)(6) 2018; body part to which device was applied: right first metatarsal; surgery description: distal bunionectomy; patient information: initials at, 35 year-old, female; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem.Event description: per tm andrew weil; during a distal bunionectomy with dr.(b)(6).2 drill bits with part # 001-a-30001 and lot b1195371 both drill bits used would not go through the bone.Or pulled a set that belonged to a competitor in order to complete the surgery.Un-retrieved guide wire w/part# 001-a-1102p lot b1204948 was left in patient's right metatarsal.This increased the duration of the procedure by 5-8min.No additional surgery required.X-rays images are attached.The complaint report form also indicates: the device failure had adverse effects on patient: left k-wire in patient's right metatarsal toe; the surgery was not completed with the device; a replacement device of the same model was not immediately available to complete the surgery; the event led to an increase in the duration of the surgical procedure of 5-8 minutes to find replacement drill bit; 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; patient current health conditions: nothing to report.Manufacturer reference number: (b)(4) distributor reference number: (b)(4).Please kindly refer also to mfr report number 9680825-2018-00061 follow up 1 and 9680825-2018-00062 follow up 1.

• Brand Name: CANNULATED DRILL BIT, 3.0/3.5MM BITE COMPRESSION SCREW, QUICK CONNECT
• Type of Device: CANNULATED DRILL BIT, 3.0/3.5MM BITE COMPRESSION SCREW, QUICK CONNECT
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 7697859
• MDR Text Key: 114295375
• Report Number: 9680825-2018-00060
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 18056099646802
• UDI-Public: (01)18056099646802(11)170831(17)220731(10)B1195371
• Combination Product (y/n): N
• PMA/PMN Number: K132893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 001-A-30001
• Device Catalogue Number: 001-A-30001
• Device Lot Number: B1195371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Date Manufacturer Received: 08/09/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR