ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE; SURGICAL BLADE
|
Back to Search Results |
|
Model Number 371111-150 |
Device Problems
Break (1069); Pressure Problem (3012)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 04/28/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
The surgeon, without applying any extra/excessive pressure, had the blade (component d2865-11) break off inside of the patient¿s shoulder on friday, (b)(6).They spent about 30 minutes retrieving the blade and i was assured the patient was ok afterwards.
|
|
Manufacturer Narrative
|
The most probable root cause is the stamping or grinding process.The customer did not provide a valid lot date but did return the sample for evaluation.The following controls are in-place to mitigate ¿broken blade¿ condition at aspen surgical (b)(4) site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.A 100% visual inspection by certified personnel is performed to segregate nonconforming material, including broken blades, prior to assembly and packaging process.Each associate performing 100% inspection process is certified and re-certified on an annual basis on blade defect criteria¿s.Capa (b)(4) was initiated to evaluate current controls in place corrective actions identified were completed and capa closed on 10/26/15.New capa (b)(4) was initiated for the broken blade defect.
|
|
Event Description
|
"the surgeon, without applying any extra/excessive pressure, had the blade (component d2865-11) break off inside of the patient¿s shoulder on friday, (b)(6).They spent about 30 minutes retrieving the blade and i was assured the patient was ok afterwards.".
|
|
Search Alerts/Recalls
|
|
|