MAUDE Adverse Event Report: SOFIC SAS PATTERSON 27G LONG NEEDLE; PATTERSON NEEDLE

Catalog Number 05N1272

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/01/2018

Event Type  Injury  

Event Description

Spontaneous report, from the us.Local reference # (b)(4).Quality complaint was opened, septodont reference # (b)(4).Quality complaint dealer reference # (b)(4).Initial information received on 01-nov-2018 by dealer sales representative and follow-up #1 information on 12-nov-2018 from the dealer by phone.Both initial and follow-up #1 information are integrated in below case narrative.On 01-nov-2018, the dentist complained of that suspect device patterson 27 gauge long needle (batch # f06844aa, exp: 2022-10) was weak at the hub, and it broke off with slight bend.Date of incident was not reported and during this episode, the patient did not "experienced" adverse reaction and damage.At time of follow-up contact on 12-nov-2018, dealer learned from the reporting dental office that the suspect device in fact was "broke" in the patient's mouth.The suspect device was inserted, then broke "twice".Patient details are not specified (age, gender, intention for dental treatment, etc.).The dentist indicated that the patient(s)'s outcome is stable and unaffected by this incident.Additional follow-up with reporting dentist is currently underway.Causality assessment performed on 20-nov-2018 on initial information received on 01-nov-2018 and additional information received on 12-nov-2018: seriousness: serious (required intervention to prevent permanent impairment/damage (devices).Listedness/expectedness: needle issue: unlisted eu, unexpected us/ca; no adverse event: listed eu, expected us/ca.Causality: latency - compatible; recognized association - no.Analysis - needle breakage occurred in the mouth of an unspecified patient while using the medical device.The possible causes of this event may be an excessive pressure or movement of the needle during injection, the use of a needle size inappropriate to the type of procedure, possible patient movements during injection due to his anxiety or needle defect.Based on the few information provided, no assessment can be performed and therefore the causal relationship between the device and the events was considered as not assessable.Dechallenge - na; rechallenge - na.Concluded causality who: not assessable.

Event Description

Follow-up information received on 22-jan-2019 from quality department with investigation results.Based on available data from quality department: no abnormality that could have an impact on the product quality was recorded during manufacturing of this batch.In the absence of the needle in question and in the absence of defect detected during our tests of both returned and reserve samples, the root cause of the reported incident could not be determined.Considering our investigation and the description of the incident, the potential cause of misuse by the practitioner cannot be set aside or validated: bending of the needle, pressure during injection exerting high force onto the cannula or excessive needle movement during injection.Moreover the nervous state of a patient may have an impact on the conditions of injection.We recommend making the practitioner aware again of the good use of the product.No further information is expected.Causality re-assessment performed on (b)(6) 2019 based on quality investigation results received on 22-jan-2019: a.Seriousness: serious (required intervention to prevent permanent impairment/damage (devices).B.Listedness/expectedness: needle issue: unlisted eu, unexpected us/ca; no adverse event: listed eu, expected us/ca.C.Causality: a) latency - compatible.B) recognized association - no.C) analysis - needle breakage occurred in the mouth of an unspecified patient while using the medical device.The possible causes of this event may be an excessive pressure or movement of the needle during injection, the use of a needle size inappropriate to the type of procedure, possible patient movements during injection due to his anxiety.Quality investigations results showed no abnormality and no defect.Therefore, based on quality investigations results, the causal relationship between the device and the events was considered as unlikely.D) rechallenge - na, e) rechallenge - na.Concluded causality who: unlikely.Follow-up received on 22-jan-2019: causality was changed from not assessable to unlikely based on quality investigations results.

Manufacturer Narrative

It is the first complaint received on 3,877,600 cannulae assembled from this batch of cannulae including 325,000 needles of this needle batch.If the problem of breakage of the cannula was related to the quality of the latter, the occurrence of the issue would be higher.No abnormality on this needle batch relating to this issue were recorded on the production/inspection records and the databases.Samples - 14 needles in a needle box - were received on november 22nd, 2018 for this complaint.Breakage tests performed on the returned and reserve samples according to iso 9626 did not evidence any abnormality (no trace of breakage).Other tests performed with a dynamometer on the returned and reserve samples, in order to measure the force required to break the cannula, did not evidence any defect (breakage values higher than 22 newtons, the value defined by sofic as an acceptance criterion, as no standard defines the minimum force of breakage of the cannula).A misuse of the needle may cause the needle to break, i.E.Bending of the needle, too strong a pressure during injection exerting force onto the cannula, excessive needle movement during injection.Moreover the nervous state of a patient may have an impact on the conditions of injection.Warnings regarding the risks related to product misuse, are clearly indicated on the product.In the absence of video showing the real conditions of the incident and the practitioner's practices, the potential cause of misuse by the practitioner cannot be set aside or validated.Quality investigations results showed no abnormality or defect of the device, therefore no safety action is deemed necessary.Final comments from manufacturer: in the absence of the needle in question and in the absence of defect detected during our tests, the root cause of the reported incident could not be determined.Considering our investigation and the description of the incident, the potential cause of misuse by the practitioner cannot be set aside or validated: bending of the needle, pressure during injection exerting high force onto the cannula or excessive needle movement during injection.Moreover the nervous state of a patient may have an impact on the conditions of injection.We recommend making the practitioner aware again of the good use of the product.

• Brand Name: PATTERSON 27G LONG NEEDLE
• Type of Device: PATTERSON NEEDLE
• Manufacturer (Section D): SOFIC SAS; 3, rue jean-jacques rousseau; aussillon; mazamet cedex, 81207 ; FR 81207
• MDR Report Key: 8122206
• MDR Text Key: 129028404
• Report Number: 3002987375-2018-00013
• Device Sequence Number: 1
• Product Code: DZM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 05N1272
• Device Lot Number: F06844AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention