MAUDE Adverse Event Report: ORTHOFIX SRL GOTFRIED PC.C.P. NECK SECOND SLEEVE

Model Number 197000

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the (b)(4) batch 01088094 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of 25 devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the second complaint notified in regards to this specific device lot.Both events occurred at the same hospital with the same surgeon.Technical evaluation: the device concerned has not yet been received by orthofix srl.The technical evaluation will be performed as soon as the device is received.Medical evaluation: the information made available on the case was sent to our medical evaluator.A preliminary medical evaluation is currently on going and will be finalized once the results of the technical evaluation and/or further information on the case are available.Orthofix srl has requested the distributor to provide further information on the event such as date of surgery, patient details and patient current health condition.As soon as further information and/or the results of the technical evaluation are available, orthofix srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.

Event Description

On august 2, 2018, orthofix srl received an email from the (b)(4) distributor who complained about a (b)(4) stating that they have two devices with the same code which feature different characteristics (total length and threads).This difference, in regards to the complained device, leads to sticking of drill bit during surgery.This problem delayed the surgery almost 30 minutes and at the end they had to change the system to a richard plate.On august 23, 2018, orthofix srl received the completed complaint form which included the following details: device code: (b)(4); batch number: 01088094; quantity: 1; hospital name: (b)(6); surgeon's name: (b)(6); date of surgery: no response; body part to which device was applied: hips; surgery description: fracture treatment; patient information: no response; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description: "during the placement of the neck screw at the time of introducing the 7mm drill bit in guide no.2, the surgeon presents great difficulty in passing the drill bit.This delays the surgery almost 30 minutes".The complaint report form also indicates: the device failure did not have any adverse effects on patient; the initial surgery was completed with the device; the event led to a clinically relevant increase in the duration of the surgical procedure (delay of 30 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: no response.Manufacturer reference number: (b)(4).Distributor reference number: email of august 2, 2018.

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 197000 batch 01088094 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.(b)(4) have already been distributed to the market.According to orthofix srl historical records, this is the second complaint notified in regards to this specific device lot.Both events occurred at the same hospital with the same surgeon.Technical evaluation: in relation to this event orthofix received the following devices: 1 gotfried pc.C.P neck second sleeve code 197000 lot 01088094 and 1 gotfried pc.C.P.7,0 mm drill bit code 186000q lot 01051688.The returned devices, received on august 25th, 2018 were examined by orthofix srl quality engineering department.The visual, dimensional and functional check did not evidence any anomalies.The returned drill bit passed smoothly inside the hole of the returned sleeve.The differences reported between the two sleeves you have (total length and threads, code 197000) could be ascribed to a different manufacturer.In fact, orthofix started manufacturing pc.C.P system in 2007.The previous manufacturer was efratgo.It is possible that the drawing of efratgo was slightly different from the one of orthofix and this could explain the difference you reported.Medical evaluation: the information made available on the event together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluation performed."this complaint from panama states that one of the drill sleeves from the pc.C.P system, 197000, was of the wrong dimensions so that the 7 mm drill bit could not pass easily through it.They seem quite definite about this and apparently the lengths of the 2 instruments are different.Apparently it was necessary to use a richards system instead of the pc.C.P.From the reporting point of view, one of the instruments of a system failed to function as it should and resulted in a 30 minute delay.The whole procedure should have taken only 30 minutes.I quite agree with this should be considered a serious injury for reporting purposes." "the findings of the technical analysis are that the drill guide was exactly in conformity with the device specifications.It is a pity that the hospital did not send us the other drill guide so that we could compare them directly.There may have been some dried organic material inside the drill guide from a previous usage.The alternative reason for the problems are that there were technical problems during the operation.So, either there were contaminants inside the drill guide, or there were technical problem during the operation." final comments: the results of the technical evaluation concluded that the returned devices were originally conforming to orthofix srl specification.The devices still perform properly.The functional issue with the drill bit could not be reproduced.Difficulties can happen when inserting the drill into the eyelet of the sleeve (e.G.In case a lateral load is applied to the drill bit causing a misalignment between the drill bit and the sleeve).However, it is always possible to insert the drill bit into the sleeve.Orthofix srl continues monitoring the devices on the market.

Event Description

On august 2, 2018, orthofix srl received an email from the panamanian distributor who complained about a device code 197000 stating that they have two devices with the same code which feature different characteristics (total length and threads).This difference, in regards to the complained device, leads to stucking of drill bit during surgery.This problem delayed the surgery almost 30 minutes and at the end they had to change the system to a richard plate.On august 23, 2018, orthofix srl received the completed complaint form which included the following details: device code: 197000 batch number: 01088094 quantity: 1 hospital name: (b)(6).Surgeon's name: (b)(6).Date of surgery: no response.Body part to which device was applied: hips.Surgery description: fracture treatment.Patient information: no response.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "during the placement of the neck screw at the time of introducing the 7mm drill bit in guide no.2, the surgeon presents great difficulty in passing the drill bit.This delays the surgery almost 30 minutes." the complaint report form also indicates: the device failure did not have any adverse effects on patient.The initial surgery was completed with the device.The event led to a clinically relevant increase in the duration of the surgical procedure (delay of 30 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: no response.Manufacturer reference number: (b)(4).Distributor reference number: email of august 2, 2018.

• Brand Name: GOTFRIED PC.C.P. NECK SECOND SLEEVE
• Type of Device: GOTFRIED PC.C.P. NECK SECOND SLEEVE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 7817559
• MDR Text Key: 118265017
• Report Number: 9680825-2018-00076
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• PMA/PMN Number: K983814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 197000
• Device Catalogue Number: 197000
• Device Lot Number: 01088094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2018
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention