MAUDE Adverse Event Report: NATUS MANUFACTURING LIMITED TECA CONCENTRIC NEEDLES

Model Number	S53153
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref natus complaint#: (b)(4).A questionnaire has been sent to the customer to complete and also a request for the needles to be returned for evaluation.
Event or Problem Description
Part: s53153, concentric needles.The customer stated: the needle disconnected from the hub and we were unable to retrieve it from the patient's leg muscle.
Event or Problem Description
Part s53153, concentric needles.The customer stated: the needle disconnected from the hub and we were unable to retrieve it from the patient's leg muscle.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint#(b)(4).Patient details were added to sections a2, a3a, a5, a6.Risk review: per (b)(4).Rev 15 risk analysis spreadsheet for teca dcn electrodes hazard 6.7 - needles are thin and flexible; needle may pull out of hub sub-assembly (loss of mechanical integrity).Effects (harm) worst case - cannula and hub sub-assembly detach, cannula is drawn inside patient (by patient muscle movement) and has to be removed surgically.Residual risk: moderate.The questionnaire was returned by the customer and it noted: the patient did not require further hospitalization and did not develop an infection.It was determined surgery was not necessary.The procedure that was conducted on the patient while using the natus device was standard leg emg study using natus diagnostic edx device along with natus s53153 needle, and the procedure took 15 minutes.The customer confirmed, only the hub of the needle will be returned, and the unused boxes of needles from the same lot.Further investigation to be carried out.
Event or Problem Description
Part s53153, concentric needles.The customer stated: the needle disconnected from the hub and we were unable to retrieve it from the patient's leg muscle.
Additional Manufacturer Narrative
Follow up report 002 ref natus complaint#(b)(4).Part s53153 lot 32d/24/t was built on work order# (b)(4).The device history record shows a total of (b)(4) needles scrapped of (b)(4) needles produced.The scrap parts were across 3 steps of the work order.(b)(4) failure overall.The overall failure of (step 70 - inspection main bevel 100%), was above the (b)(4) however the rejected quantities recorded on the device history record show the (b)(4) was exceeded once.At (step 70 - inspection main bevel 100%), a quantity of (b)(4) on (b)(6) 2024 does not exceed the (b)(4) but the quantity of (b)(4) did exceed the (b)(4).On this occasion an engineer was called and assessed the issue.This issue related to the grinding of the main bevel.The grind wheel was found to be faulty.This issue does not relate to the needle disconnecting from the hub.The engineer instructed the wheel to be changed and production to continue.The quantity of (b)(4) units at (operation (b)(4) - automatic assembly), are where the testing for the komax 4 assembly is performed.The hub to cannula tensile test and hub to colour cover retention show all tests passed.The device history record shows no anomalies for the complaint.No related capa.From this investigation, the device history record review did not show any anomalies for the complaint including a review of all applicable measurements.No product examination as the product was not returned.
Additional Manufacturer Narrative
Follow up report 003 ref natus complaint# (b)(4).The risk file (b)(4) for the teca dcn electrodes was updated to rev 16.The risk / benefit analysis for hazard 6.7 was updated as follows: the hazards identified have been reduced as far as possible, and the residual risk for these hazards is mainly associated with the needle having wrong specification/ manufacturing defect.The device is designed and manufactured to mitigate the risk of a faulty needle reaching the customer and the risk is reduced as far as possible by performing 100% inspection of the needles.The remaining risk associated with the use of the product is outweighed by the benefit of its intended use.
Event or Problem Description
Part s53153, concentric needles.The customer stated: the needle disconnected from the hub and we were unable to retrieve it from the patient's leg muscle.

• Brand Name: TECA CONCENTRIC NEEDLES
• Common Device Name: TECA CONCENTRIC NEEDLES
• Manufacturer (Section D): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; ida business park; gort; galway, H91PD-92 ; EI H91PD92
• MDR Report Key: 20897564
• Report Number: 3005581270-2024-00008
• Device Sequence Number: 5004607
• Product Code: IKT
• UDI-Device Identifier: 00382830017480
• UDI-Public: 00382830017480
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/27/2025

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
• Operator of Device: Health Professional
• Device Model Number: S53153
• Device Catalogue Number: S53153
• Device Lot Number: 32D/24/T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/09/2025; 05/06/2025; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White