MAUDE Adverse Event Report: TECHNOMED EUROPE CADWELL; DISPOSABLE SUBDERMAL NEEDLE ELECTRODE

Model Number	302875-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Burn(s) (1757); Foreign Body In Patient (2687)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Technomed received complaint via distributor cadwell 10 march 2026 with regards to the subdermal needle part number: 302875-000 (needle, parallel,14x0.38mm (27g) 100in12pr), either lot: 103210: the complaint is that the needle broke off in the patient, requiring an additional procedure to remove it.The event date was today, march 10th."while removing needles at the end of the case, i noticed one sharp had broken off above the hub from the left vl muscle.I checked the tape and surrounding area but could not find the sharp.I immediately notified the rn and resident who was still in the room.We both felt around the insertion area (which also showed two burn marks); neither of us could feel the needle and we were not certain it was in there.I suggested we ask (b)(6) to come back in the room to confirm the sharp was no longer in the patient.The resident agreed.Flat plate images were taken and the broken sharp was located.Dr.(b)(6) came back into the operating room and performed another procedure to removed the sharp.This ended up in an additional hour of operating room time, additional (b)(6) time, additional local anesthetic, silver nitrate matchsticks for hemostasis and two 2.0 monocryls." the event occured during the following procedure: t10-pelvis posterior fusion.
Event or Problem Description
Technomed received complaint via distributor (b)(4) 10 march 2026 with regards to the subdermal needle part number 302875-000 (needle, parallel,14x0.38mm (27g) 100in12pr), either lot 103210: the complaint is that the needle broke off in the patient, requiring an additional procedure to remove it.The event date was today (b)(6)."while removing needles at the end of the case, i noticed one sharp had broken off above the hub from the left vl muscle.I checked the tape and surrounding area but could not find the sharp.I immediately notified the rn and resident who was still in the room.We both felt around the insertion area (which also showed two burn marks); neither of us could feel the needle and we were not certain it was in there.I suggested we ask fluoro to come back in the room to confirm the sharp was no longer in the patient.The resident agreed.Flat plate images were taken and the broken sharp was located.Dr (b)(6) came back into the or and performed another procedure to removed the sharp.This ended up in an additional hour of or time, additional fluoro time, additional local anesthetic, silver nitrate matchsticks for hemostasis and two 2.0 monocryls." the event occured during the following procedure: t10-pelvis posterior fusion.
Additional Manufacturer Narrative
Technomed completed its investigation of the needle fracture (dsne a017870, lot 103210).The physical sample was not returned; analysis is based on photographic evidence and retain sample testing.The most probable root cause is a single-cycle bending overload at the skin insertion point, likely precipitated by electrocautery use during the procedure, a risk addressed in the device instructions for use.Retain sample testing (lot 103210, 102299, 102143) and batch records confirmed no material or manufacturing defects.

• Brand Name: CADWELL
• Common Device Name: DISPOSABLE SUBDERMAL NEEDLE ELECTRODE
• Manufacturer (Section D): TECHNOMED EUROPE; wiebachstraat 25a; kerkrade; kerkrade, limburg 6466N G; NL 6466NG
• Manufacturer (Section G): TECHNOMED ASIA; k.i trikencana kav. 4-5, jl; kopo katapang km 11; bandung, jawa barat 40921 ; ID 40921
• Manufacturer Contact: isabelle fiandaca ; wiebachstraat 25a; kerkrade; kerkrade, limburg 6466N-G ; NL 6466NG
• MDR Report Key: 24752006
• Report Number: 9710376-2026-00002
• Device Sequence Number: 10101912
• Product Code: GXZ
• UDI-Device Identifier: 08720791376604
• UDI-Public: 08720791376604
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 302875-000
• Device Catalogue Number: A017870
• Device Lot Number: 103210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female