MAUDE Adverse Event Report: NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number	405079
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial reporter also notified the fda on 23 march, 2021.Medwatch report # (b)(4).Report source other: medwatch report.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that needle spinal s/su 27ga 3-1/2in whitacre guidewire broke.The following information was provided by the initial reporter: material no: 405079 batch no: unknown.It was reported that the 3 cm whitacre spinal needle tip that broke off at time of spinal block at beginning of total hip replacement.Verbatim: we are in the process of a completing a medwatch report, which will detail the occurrence.(b)(6) female patient.Additional length of surgery time (around 50 minutes additional or time after completion of scheduled total hip replacement); additional surgical procedure by spine surgeon to remove unintentionally retained 3 cm whitacre spinal needle tip that broke off at time of spinal block at beginning of total hip replacement.Patient remains in-patient at hospital s/p total hip replacement surgery.Additional information will be in medwatch report.
Additional Manufacturer Narrative
H6: investigation summary: one actual sample was received by our quality team for evaluation.Upon visual inspection of the sample it was observed that the cannula was broken (no handle/stylet was sent) and that near the breakage the cannula was bent.A device history record could not be evaluated as the lot number is unknown.Based on the investigation, the possible root cause can be directed to possible handling issues based on the evaluation of the sample received.The sample had a notable bend on the cannula which can be indicative to bending and repositioning.The ifu states that ¿repeated repositioning may increase the risk of needle breakage¿ and ¿remove spinal needle and introducer needle together¿.As it is explained in the ifu, this practice may increase the risk of needle breakage and therefore it is not recommended.This incident has been added to our database of reported incidents.
Event or Problem Description
It was reported that needle spinal s/su 27ga 3-1/2in whitacre guidewire broke.The following information was provided by the initial reporter: material no: 405079; batch no: unknown.It was reported that the 3 cm whitacre spinal needle tip that broke off at time of spinal block at beginning of total hip replacement.Verbatim: we are in the process of a completing a medwatch report, which will detail the occurrence.65 year-old female patient.Additional length of surgery time (around 50 minutes additional or time after completion of scheduled total hip replacement); additional surgical procedure by spine surgeon to remove unintentionally retained 3 cm whitacre spinal needle tip that broke off at time of spinal block at beginning of total hip replacement.Patient remains in-patient at hospital s/p total hip replacement surgery.Additional information will be in medwatch report.

• Brand Name: NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• MDR Report Key: 11697806
• Report Number: 2618282-2021-00024
• Device Sequence Number: 11543583
• Product Code: BSP
• UDI-Device Identifier: 00382904050795
• UDI-Public: 00382904050795
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: Other
• Device Catalogue Number: 405079
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 06/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 65 YR